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Business Operations Analyst AMN Healthcare To read the full description and apply: www.amnhealthcare.com/workatamn.aspx
The Staff Business Operations Analyst works with cross functional management members and end users of corporate Sales Order (CRM), Enterprise Resource Planning (ERP) and Support Delivery (SD) systems to improve business process in alignment with corporate strategic goals. Staff Business Operations Analyst will work with Information Technology (IT) and business owners to document business processes and workflow, and suggest streamlined improvements. In turn this role will partner with IT personnel to gather requirements and propose the design of Functional Specifications to affect appropriate business process re-engineering (BPR). The primary goal of the Staff Business Operations Analyst will be to provide streamlined solutions to ongoing business challenges thereby removing complexity and improving customer satisfaction of both internal and external customers.
Requirements: o Proven project management and leadership skills, including the ability to gather clear business requirements. o Proven ability to develop, document and maintain operational policies and procedures, including the designing and documenting detailed process flows, and the development of operational performance and quality metric standards and reports. o 2-3 years of related experience and/or training as a Business Analyst. o Six sigma or BPR experience and/or certification preferred. o Systems implementation experience preferred. o Experience in a fast paced, external facing Customer Support department preferred or 1+ years working with accounts receivable, payroll, billing or general accounting areas. o Experience with functional and/or technical aspects of enterprise software packages and custom development (PeopleSoft 8.0 or higher Sales Order process).
Chip Livingston Corporate Recruiter AMN Healthcare www.amnhealthcare.com 858-350-3227 direct 858-225-0645 fax
Associate Director, Quality Assurance job Code #08-009
This position will develop, coordinate, and implement FDA regulated quality programs required for a pharmaceutical development organization, and provide guidance necessary to maintain compliance to applicable regulations (e.g., GMP, GLP, and GCP). The individual will manage quality assurance activities supporting the manufacture of active pharmaceutical ingredients and drug product at contract manufacturing organizations, and the activities supporting release and stability testing of same at contract testing facilities.
Specific duties include: " Providing oversight of contract manufacturers, testing laboratories, packaging/distribution/storage facilities " Participating in the evaluation, qualification and auditing of contract organizations " Reviewing records and data associated with clinical trial materials, and disposition for use " Reviewing records and data associated with GLP activities " Serving as a member of the QAU in support of internal GLP activities " Designing and implementing training programs " Assisting in the development, implementation and maintenance of the MTI Quality Systems " Interpreting, and educating organization on, regulations/standards " Developing and implementing corrections/efficiencies
Qualified candidates will possess: " BS in related field, and 8-12 years related experience in FDA regulated pharmaceutical and/or biotech industry, with a minimum of 8 years in a Quality Assurance function. " Comprehensive and up-to-date knowledge of and experience with cGMP and GLP requirements, familiarity with GCP requirements and FDA and EU regulations and applicable regulatory guidance documents " Ability to work successfully with multinational, interdisciplinary project teams and proven ability to influence and collaborate effectively " Working knowledge of drug development processes, analytics " Ability to plan and coordinate activities simultaneously on multiple projects under pressure of time and workload " Excellent attention to detail without losing sight of overall goal Metabasis Therapeutics, Inc. is a San Diego-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapies to address some of the world's most widespread and costly chronic diseases. Metabasis has a broad product pipeline targeting large markets with significant unmet medical needs. We are specifically focused on metabolic diseases involving pathways to the liver, such as diabetes and hyperlipidemia, as well as liver diseases such as hepatitis and liver cancer. We currently have five internally discovered product candidates in clinical development as well as an active discovery team seeking additional product candidates to treat metabolic diseases.
Metabasis Therapeutics is an equal opportunity employer offering a competitive compensation package including a stock option program & comprehensive benefits, in a fast-paced, highly stimulating, team-oriented environment. Qualified applicants are invited to submit a resume and cover letter to: Metabasis Therapeutics, Inc. Human Resources Dept. 11119 North Torrey Pines Road La Jolla, CA 92037 Fax: (858) 458-3504 jobs@mbasis.com www.mbasis.com
Director, CMC Regulatory Affairs & Quality Systems Ambrx, Inc., located in San Diego, CA is a biopharmaceutical company with a mission to deliver breakthrough protein therapeutics. See www.Ambrx.com
Responsibilities include: " Develop and implement global CMC regulatory strategies; " Identify and assess regulatory risks associated with product development, and develop and implement strategies to minimize risks; " Develop, implement and maintain compliance with quality systems and processes; " Provide regulatory CMC and quality systems guidance to Company personnel; " Perform periodic cGMP and cGLP audits of, and assist in the qualification and ongoing management of, suppliers and contract manufacturing and research organizations; " Prepare clear, accurate and effective regulatory submissions; " Represent the Company in interactions with regulatory authorities, contractors and corporate partners " Monitor and analyze appropriate regulatory authority activities in areas of interest; " In close coordination with the Company's clinical development leadership, provide guidance and assist in the development of the Company's overall global regulatory strategies; and " Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
Qualifications: " Bachelors, masters or PhD degree in a scientific discipline and minimum of seven (7) years experience in a regulatory drug development environment; " Demonstrated record of preparing and successfully prosecuting major regulatory submissions; " Strong, working knowledge of current regulatory requirements in the US (FDA) and Europe (EMEA); " Experience in assessing compliance of CMC documents with applicable regulatory guidelines and regulations relevant to manufacturing, pre-clinical, and clinical development of protein-based therapeutics; " Experience in assessing impact of proposed CMC, clinical protocol and other changes to licenses and clinical trial applications; " Experience in interfacing successfully with regulatory authorities in the US and EU; " Capability to oversee and prepare well organized, cogent and scientifically valid document packages for regulatory submissions from all areas of company; Capability to conduct internal and external GMP and GLP audits and inspections; " Excellent managerial, analytical, organizational, and interpersonal communication skills; " Ability to manage multiple projects simultaneously, and to present oral and written information in an organized and succinct manner; " Ability to travel extensively as required to perform cGMP and cGLP audits of, and assist in the qualification and ongoing management of, suppliers and contract manufacturing and research organizations.
Please send resumes to: Jorgjobs@yahoo.com Attn: Alda Jorgenson, Recruiting Consultant for Ambrx, Inc.
JOB TITLE: Quality Engineer Delta Design, Inc. Contact: Robert Navarro at rnavarro@deltad.com Position Summary: Acts as quality process liaison between customers, suppliers, and internal functions (sales, manufacturing, quality assurance, and engineering) to define, analyze, and resolve customer supplier quality issues. Position Purpose: The purpose of the Quality Engineer position is to facilitate business performance excellence. This is accomplished using tools, methods, and models to recognize and then break through barriers inhibiting necessary improvements from occurring and or keeping effective changes from sustaining. Essential Functions/Major Responsibilities: 1. Understand and clearly define all aspects of customer and supplier quality problems and/or issues and facilitate satisfactory resolutions using data collection, root cause and trend analyses. 2. Identify, define, and apply the elements of process documentation systems, such as configuration management, document control, and ISO standards. 3. Identify, define, and classify quality characteristics, including classification of defects. Create qualification methods and metrics for process, product, and service delivery. 4. Analyze customer feedback and field data to identify potential product safety issues. 5. Responsible for developing, tracking, and modifying project timelines. 6. Coordinate ongoing compliance activities (internal quality audits, corrective/preventive actions, training, etc.) which are required to maintain compliance with ISO 9002 certification. 7. Travel may be required. 8. Other duties as required. Supervisory Responsibility: Qualifications: ¢ Education: Bachelor's degree or equivalent, relevant experience in an Engineering or Quality discipline. CQE and ISO Lead Auditor certification preferred. ¢ Experience: 1-3 years related automated test equipment or semi-conductor industry experience. Thorough knowledge of ISO 9000 series quality standards. ¢ Skills/Technical Requirements: Excellent verbal and written communication skills and strong interpersonal skills to deal with all levels of the organization. Project coordination skills. Computer literate in MS Office and timeline software. Familiar with probability and statistical tools and FMEA. Job Conditions: Office/manufacturing/lab environment. Some travel may be required. Physical Demands/Strengths: Walking, sitting, standing, bending. Protective Devices Required: In required areas.
Director of Quality Assurance (DQA) Contact Michael Boyle a call at (949) 474-3354 or email him at mike@bobsearch.com
Senior Quality Specialist GXP Company: Ardea Biosciences is focused on the discovery, development and commercialization of novel treatments for HIV, cancer and inflammatory diseases. Visit us at www.ardeabio.com Respond to: Send your resume to: careers@ardeabio.com
Summary The successful candidate will assure cGXP compliance with applicable regulatory requirements including audits, training programs and documentation review. Responsibilities " Represents and interfaces with multiple departments to provide Good Manufacturing Practices and Good Laboratory Practices guidance in an effective manner. " Reviews production batch records and associated data for product release; determines if records are within range of cGMP regulations. " Develops, revise, and reviews GXP Standard Operating Procedures. " Performs internal GXP audits and or assists in the coordination of audits from outside parties. " Addresses, resolves and mediates corrective actions in GXP audit findings and prepares written reports as necessary; ensures training of internal staff as appropriate. " Conduct vendor qualification audits for Contract Manufacturing and Research Organizations. " Trouble-shoots and takes the initiative on any QA-related issue for GXP compliance. " Ensures completeness and accuracy of information contained in all documents, document files, databases and document management systems. " Reviews protocols, study reports, etc. for product release; ensures that no deviations from approved protocols were made without proper authorization/documentation were performed in accordance with the GXP guidelines. " Carry out job responsibilities and assignments safely and maintain a clean and safe work area. " Other duties as may be necessary.
Preferred Requirements " Bachelor's (BS) in the Life Sciences or related discipline. " At least four to six years' experience demonstrated experience in the QA responsibilities listed above. " Strong knowledge of GMP regulations and good documentation practices. " Strong writing skills in protocols, SOPs and QA reports. " Must have ability to listen, communicate effectively (both orally and in writing) and to interact with all levels within the organization. Excellent reasoning, interpersonal and organizational skills, and superior attention to detail. " Extensive skills, knowledge and abilities with computers and software programs including Word, Excel, and document management programs. " High attention to detail, and the ability to work in a fast-paced and team environment. " Some travel may be required. With headquarters in San Diego, Ardea Biosciences is focused on the discovery, development and commercialization of novel treatments for HIV, cancer and inflammatory diseases.
Software QA Engineer (San Diego) <sponsored post> The company is a leading global provider of workforce optimization software and services that provide businesses with visibility into customer service processes, workforce performance, and customer intelligence.
The Position: The Software QA Engineer works with members of the R&D Organization and is responsible developing test plans and strategy, and execution of those plans for each release. The Software QA Engineer has knowledge of commonly used test concepts, practices and procedures. There is minimal travel required for this position.
Qualifications Competencies: "Experience writing and analyzing SQL queries." Hands on experience installing, configuring, and testing databases " Comfortable configuring and testing websites (particularly IIS) " Comfortable with Windows Server Operating Systems. (ie. viewing/ configuring services, event logs, ftp, file permissions, editing the registry). " Previous testing experience with some (preferably most) of the following technologies: o .Net o XML, SOAP o HTML o Enterprise Java. " Experience in testing tools such Quality Center. " Experience in business and/or financial solutions software is preferred. " Nice to have, but not required experience: Test Automation, script (vb, perl etc) writing. Interpersonal Skills: " Proven ability to gain cooperation of others, and tasks completed on time. " Excellent oral and written communication skills and ability to interface to senior levels of an organization is required. " Highly motivated, hands on personality. Education/Experience: " At least 5 years of QA Testing Experience. " Degree in Technology is preferred.
Interested: Forward your confidential resume and contact information to david@mis-consulting.net
Quality Systems Analyst <position filled>
Several Software Quality Assurance Engineers ViaSat is growing rapidly and is considered one of San Diego's "Best Places to Work" Location: Carlsbad, CA Education: BA/BS Travel: up to 10% U.S. Citizen: Required
Job Responsibilities: " Meet software quality assurance contractual obligations, including performing audits, witnessing of key software activities, reviewing software documentation for compliance. " Work closely with the software engineering community at ViaSat to help facilitate software process adoption and corporate tool usage. " Define, measure, analyze, and prepare reports on software metrics. Experience Required: " Good interpersonal coordination skills " Good understanding of the software development process " Good understanding of the conduct of quality audits " Familiarity with handling classified materials, clearance preferred " Familiarity with configuration management, knowledge of Perforce helpful " ASQ certified for software quality assurance preferred " Working knowledge to analyze, report and make recommendations based on software metrics " Proficient at MS Office tools " Understanding of CMMI model for process improvement
If you are interested, or know someone that might be interested, please go to: www.viasat.com/careers
Sr. Quality Engineer INNERCOOL therapies, Inc. is a medical technology company focused on the emerging field of therapeutic hypothermia. Please visit our website at: www.innercool.com for additional information on our company. Send resumes to crojas@cardiumthx.com This position takes a leadership role in Quality Engineering, Reliability and Regulatory Compliance through support of new product development, overseeing the internal audit and corrective/preventive action programs, maintaining the sterility assurance and environmental monitoring activities and implementing process improvements within the quality management system. This position reports directly to the Director of Regulatory Affairs and Quality Assurance. Essential Job Functions: Work with product development teams in reviewing design inputs to ensure compliance to domestic and international regulatory requirements such as, electrical safety, electromagnetic compatibility, labeling, reliability, biocompatibility, etc. Assist product development and production in initial and ongoing risk management reporting. Support supplier quality through vendor assessments, inspection plans, root cause analysis on nonconforming goods and quality trending. Manage the activities for ensuring timely and effective corrective and preventive actions plans. Oversee the internal auditing program for assessing the effectiveness and compliance of our quality management processes, and identifying opportunities for improvements. Assist in statistical trending of customer complaint data and provide technical support for evaluation of returns. Maintain sterility assurance program, including bioburden sampling, sterilization validations, routine sample processing and environmental monitoring of production areas. Support production or process changes through development of validation protocols/reports and utilization of statistical techniques (e.g., design of experiments, repeatability studies, . Oversee equipment calibration program. Participate in regulatory and ISO audits. Qualifications: Education: BS degree in Life Science or Engineering. Experience: 5-7 years of direct medical device experience with sterile disposable and/or electromechanical products. Thorough knowledge of FDA Quality System Regulations and ISO 13485 Requirements. Familiarity with European Medical Device Directive and Canadian Medical Device Regulations a plus. Experience with sterilization validations of devices a plus. Specific Skills/Knowledge: Works well in a fast paced, team environment. Excellent communication skills (written & verbal). Quick learner and capable of being successful in achieving goals with limited supervision. Resourceful and self motivated. Good interpersonal skills, experienced in conflict resolution. Familiar with Biocompatibility, Sterilization Validation, etc a Plus
Quality Systems Analyst
Quality Inspector Compucraft Industries is located in Santee, CA. Applicants can send their resume to Gerdell@Ccind.com
Summary: Review raw materials and manufactured products at Receiving Inspection, In-Process and Final Inspection to ensure conformance with Work Order planning, engineering drawings and customer specifications. Essential Duties and Responsibilities: The following duties will be performed in addition to other requirements assigned by the Quality Manager. · Verify physical properties of material such as sheet metal, bar stock, castings, and other product characteristic to ensure material is in compliance. · Use facility equipment to verify compliance with planning, drawings and specifications. · Test hardness, conductivity, weld integrity, and plating thickness as assigned. · Perform calibration on equipment and tooling in accordance with established procedures. · Record and process nonconforming material for Material Review Board (MRB) action. · Ensure company compliance to established procedures and processes. · Seek ways to improve / streamline inspection methods and communication channels. · Focus on manufacturing demands by multi-tasking and meeting schedule deadlines. · Cooperative behavior and a helpful attitude.
Position Requirements: · High school graduate, with good English reading / writing and math skills. · One or more years experience working within an AS 9100:2004 quality system. · Strong attention to detail in all work output. · Ability to understand and interpret blueprints / drawings and work procedures. · Use calipers, micrometers, gages, tooling fixtures and other inspection equipment. · Familiar with Microsoft Office products such as Word and Excel, and prior knowledge with an automated Material Requirements Planning business system. Capable of occasionally lifting up to 25 pounds.
Quality and/or Manufacturing Engineer Job Description: Responsible for providing leadership in the Quality and Manufacturing Engineering function. Ensure the prevention of product performance issues, resolve reported quality and manufacturing issues, support New Product implementation. Perform Process and Product evaluations for continual improvement, product quality, efficiency and cost saving methods. Develop and write Quality and Manufacturing work instructions.
Job Requirements: " Bachelor's Degree in Engineering, or other related field. " 5 to 10 years of experience working in regulated design environments (specifically electrical device development, ISO registered work experience) and experience in Manufacturing Processes and UL, IEC standards. " 2 years Engineering experience in an Electronics, Manufacturing environment " Excellent verbal and written communications skills " Excellent computer skills and knowledge of Microsoft Office software. Other Preferred Qualifications: " Knowledge and experience with ISO13485 Requirements and FDA QS Regulations. " Ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude. " Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment. " Advanced degree " ASQ Certified Quality Engineer
Please email resume to Steve Freeman, VP of Quality Assurance at Outsource Manufacturing, Inc. steve@outsourcemfg.com , or fax to 760-795-1296.
Quality Engineer Compucraft Industries is located in Santee, CA. Applicants can send their resume to Gerdell@Ccind.com
Summary: Develop, implement, modify and maintain quality standards for products and processes in a fast-paced AS 9100:2004 environment. Responsible for guidance in technical evaluations, quality analysis, and related data acquisition processes to ensure that quality objectives are achieved. Essential Duties and Responsibilities: The following duties will be performed in addition to other requirements assigned by the Quality Manager. Develop and establish procedures and work instructions in accordance with the AS9100:2004 standard, quality performance trends and technical quality plans for new product. Ensure that project and process control documentation is compliant with contractual requirements. Assess quality performance and the cost-of-quality using statistical and analytical methods. Create and implement various methods and procedures for inspection, testing and evaluation of the reliability and accuracy of products, processes and manufacturing equipment. Provide input on quality to product development teams. Establish goals, objectives and metrics required to complete projects. Recommend producibility improvements by facilitating process reviews and assessing technical data packages, manufacturing methods, equipment, tooling and training. Analyze proposed changes in methods and materials. Identify quality trends and coordinate corrective action with customers and suppliers. Ensure compliance to specified quality requirements by performing in-house and supplier audits and surveys. Develop and initiate programs to improve supplier performance. Develop inspection sampling plans by applying attribute, variable and sequential sampling methods. Create instructions for recording, evaluating and reporting on quality data. Prepare comprehensive reports by collecting, interpreting, analyzing, and summarizing data. Act as member of the Material Review Board and participate in related activities, failure analysis and corrective action investigations. Refine and enhance products and processes by applying continuous improvement and Lean manufacturing principles and techniques in critical areas. Represent the company by interfacing with customers and regulatory agencies, and by assisting with internal / external audits. Develop and coordinate corrective action plans and procedures. May provide direction to quality inspectors and individuals across the company. Coordinate cross-functional or project team responsibilities such as continuous improvement initiatives. Familiar with the capabilities, limits and operation of advanced inspection tools including CMM (Cordinate Measuring Machine) using Virtual DMIS software or similar software applications.
Position Requirements: Bachelors degree (BS) in Engineering or a related technical discipline or equivalent experience. Demonstrated ability to perform the essential functions of the job typically acquired through six or more years of related experience.
Quality Manager Signet Armorlite, Inc., a leading manufacturer of ophthalmic lenses, is seeking a qualified individual to lead quality efforts at its San Marcos, California facility.
The position is responsible for coordinating and directing the quality assurance program, developing standards and test methods, and maintaining records and procedures per GMP.
The successful candidate will have a proven track record of establishing procedures and test methods, records maintenance, an excellent working knowledge of measurement and statistical methodologies, and the ability to interface with employees at all levels, as well as suppliers and customers.
Qualified candidates will have an Engineering degree, 5 years of experience in Quality and supervisory experience. ASQC certification and completion of additional Quality coursework is strongly desired. Salary commensurate with knowledge and experience.
We offer a competitive salary and complete benefits package including immediate vesting 401(k) with match, tuition reimbursement, medical, dental and life insurance. Send your resume with salary requirements to: Signet Armorlite, Inc. Attn: Human Resources 1001 Armorlite Drive San Marcos, CA 92069 Fax: (760) 471-6255 Email: smorales@signetarmorlite.com
Johnson Matthey, a globally recognized supplier of micro machined components for the Medical Device Industry, has an immediate need for a Quality Engineer. Key responsibilities are for quality improvement and process engineering in a fast paced multi-line production environment. This includes the assurance of process capability, project implementation and facilitating quality improvement teams. The successful candidate should be able to identify problems, lead continuous improvement and implement solutions. This is an excellent opportunity for process ownership. Responsibility also exists for ISO 9000:2000 internal and supplier auditing. Applicants should possess a B.S. degree in an engineering discipline and at least two years experience in a manufacturing environment. Six Sigma, Lean Manufacturing and/or CQE certification is recommended. Experience is desired in both quality and process engineering, including demonstration of past successes in the identification and implementation of improvements with measurable results. Experience in micro-machining is desired. We offer a state of the art facility, excellent working conditions, competitive salary and benefits package. For consideration, please send your resume with salary/history requirements to: JOHNSON MATTHEY DEPT HR 12205 WORLD TRADE DRIVE SAN DIEGO, CA 92128 EMAIL: BOESSNE@JMUSA.COM FAX: 858-716-2336 No Phone Calls Please. EOE.
Job Title: Q.A. Inspector <position filled>
Staff SW Quality Engineer Provide Quality Engineering support to the Software Engineering and Program Management organizations to assist in Process Development, Mapping, Flowcharting, Documentation and Training to effectively roll out SCM changes and implement best practices within ASW and AST. Collaborate with Software Engineering, Applications and other cross functional team members to address process improvement initiatives in Configuration Management, Gate Reviews, Readiness Reviews and Corrective Action investigations. Bringing recommendations to SW Eng team to improve SW quality and increase process efficiency and effectiveness. Collaborate with procurement and software engineering to review software supplier controls and systems. Min. 8 years experience with 2-3 significant/industry recognized SW developers. Experience with SW code development, test, and debug. -Understands industry best practices for SW development -Software Quality Assurance experience required - Able to balance theoretical vs. practical CMMI application and make solid recommendations -Certification a plus. -Understands and frequently uses problem solving, benchmarking practices and statistical analysis tools. -Solid understanding of process evaluation and development -Experienced in managing projects with significant resource and schedule constraints -Excellent verbal and written communication skills -Self-driven motivated individual. Is practical, willing to roll sleeves up and both learn and contribute. -Open and friendly personality with strong teamwork skills a must. Ability to interact with a diverse engineering groups, including senior management. -6 Sigma knowledge a plus. Please apply online at www.qualcomm.com/careers and use this job # G1795893
Sr. Process Engineer Process Development and Improvement " Defines systems and processes to manage and improve organizational effectiveness " Provides support for engineering and operations in developing process maps and documentation to communicate key processes and promote consistency " Facilitates process re-engineering or process design activities " Identifies and develops process indicators to monitor process effectiveness " Enables communication of lessons learned to design teams using system solutions " Provides feedback on the effectiveness and efficiency of the QMS to individual teams Corrective and Preventive Action " Facilitates corrective and preventative action sessions with engineering and other QCT groups " Provides facilitation of CAPA sessions " Trains QCT groups to perform independent CAPA sessions " Identifies and facilitates process improvement teams that result from CAPA sessions " Monitors CAPA effectiveness Process Assessments " Participates in 'improvement oriented' process assessments " Initiates improvement activities to address findings " Excellent communication, facilitation and presentation skills required. " Comfortable facilitating improvement activities at all levels " Good interpersonal & negotiation skills with internal groups " Good analytical skills. " Experience with developing charts and graphs. " Experience with releasing/publishing processes to a larger organization for a successful acceptance " Focused on execution and results oriented " Business modeling toolset a plus " Highly organized Job Requirements & Experience Needed: " Experienced in process modeling and process development " Knowledge of quality and improvement tools required " Ability to function in a dynamic team environment is necessary " Experienced in the development, implementation and maintenance of quality management systems " 5 or more years experience in 'Quality Improvement' disciplines " Experience in the semi conductor industry preferred. Solid understanding of the chip design business a plus. Educational Requirements: B.S degree in Engineering or related field, additional business degree desirable.
Please apply online at www.qualcomm.com/careers and use this job # E1787933
EISI (Emerging Information Systems, Inc.), an industry leader in North America for professional financial planning software is currently seeking an innovative Quality Assurance Specialist to join our team. The Quality Assurance Specialist is responsible for carrying out established procedures to ensure all of the products meet company and client standards. This involves thoroughly testing of applications to ensure proper operation and freedom from defects. Will provide workflow analysis and quality improvements. The candidate will be responsible for verifying that the software complies with the documented requirements and for implementing test plans and testing the applications to ensure proper functionality and freedom from defects. The QA Specialist will create test plans and test results analysis. Will also develop and document the application test cases based on business requirements, as well as the execution and validation of test cases. In general, this individual will be responsible for quality assurance / control during the testing and production phases of all software development projects. A qualified candidate will have a Bachelor's degree in a technical discipline and at least 1 year in financial services, software testing or technical software support role; or equivalent combination of education and experience. Must have exposure to web and desktop technologies (IIS, XML, and .NET) and experience testing complex distributed software implementations. Ideally, a candidate will have worked with MS-SQL databases and has some experience with QA processes. Knowledge of financial planning and / or the financial services industry is a strong plus. Must be able to clearly demonstrate the ability to organize, plan and test software applications. This position is a part of a team but involves the ability to work independently under pressure and within set deadlines. Must be detailed and have strong communication skills. EISI is conveniently located in Carlsbad, CA and offers challenging career opportunities, a comprehensive employer-paid benefits package, 401(k) with matching, flexible hours and a family-like environment. EISI's superior compensation package recognizes and rewards both individual performance and business results.
Qualified applicants are invited to submit their resumes to: careers@eisi.com . Please be sure to put the position title in the subject of your email submittal.
Document Control Administrator <position filled>
Job Title: Quality Engineer, Level 2 (Intermediate)
Responsible for developing, applying, revising, and maintaining quality standards for processing materials into partially finished or finished products. Job Content: " Designs and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and/or production equipment. " Analyzes reports and returned products, and recommends corrective action. " Prepares documentation for inspection/testing procedures. " Responsible for locating, reading, and comprehending the Overland Quality Policy. " Complies with Overland Quality policies and procedures and supports ISO programs and efforts. " Typically receives general instructions on routine work; detailed instructions on new assignments.
Job Qualifications: Experience: Min 2-5 yrs job-related experience, including product planning. Education & Training: BS degree or equivalent. Knowledge of inspection methods in the design, fabrication, and production of electronic equipment. Skills, Knowledge, & Abilities: Good written, verbal, and interpersonal skills. Ability to solve a variety of problems by reviewing identifiable factors. Working knowledge of Microsoft Office. Reading, writing, hearing, talking, visual acuity, grasping, gripping, lifting 6-15 pound parts for inspection (~10-15% of the job). Requires confidentiality, ability to take direction and complete assignments as necessary, and ability to work effectively under deadline pressure. This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities that management may deem necessary from time to time.
Status: Exempt Job Code: 4652; Reply to BCarter@overlandstorage.com
QUALITY ENGINEER COMPANY OVERVIEW: Teledyne RD Instruments, Inc., located in Poway, CA, specializes in the design and manufacture of underwater acoustic Doppler products for a wide array of current profiling and precision navigation applications. Originally founded as RD Instruments, the company was formed as a result of the development of the industry's first Acoustic Doppler Current Profiler (ADCP), a revolutionary device capable of profiling currents at up to 128 individual points in the water column was developed. The company currently has over 200 employees and resides in a 80,000 square foot ISO-9001:2000 facility that includes state-of-the art engineering, laboratory, manufacturing, and test areas.
JOB DESCRIPTION: Identifies, collects and analyzes data through the use of statistical techniques, and determines and implements corrective actions to improve processes and procedures. Monitors and evaluates supplier performance by using failure data. Investigates and resolves problems associated with incoming, in-process and final inspection. Performs supplier evaluation and re-evaluation. Creates metrics and recommends areas of improvement. Develops and implements supplier quality plans.
JOB REQUIREMENTS: Bachelor's degree in an Engineering or Quality discipline. Five (5) years related experience in a manufacturing environment. Knowledge of cause and effect diagrams is required. Proven success in a continuous improvement environment is essential. Extensive knowledge of troubleshooting using engineering drawings and schematics is mandatory. Limited travel may be required. Experience in a Lean Manufacturing, Six Sigma, and 5S environment is preferred. Knowledge on SMT PCA lines is a plus.
HOW TO APPLY? Teledyne RD Instruments offers a very competitive compensation and benefits plan. Visit us at www.rdinstruments.com for information. Interested candidates should email their resumes with pay history to mmilligan@teledyne.com . Teledyne RD Instruments is an Equal Opportunity Employer M/F/D/V employer. No phone calls please.
Senior Internal Auditor The Cardinal Health Internal Audit department is seeking motivated, audit professionals for Senior Auditor positions. The Quality and Regulatory Affairs group supports Clinical Technologies and Services through continuous improvement of our business processes. The group works with business owners to drive customer satisfaction, define, simplify, and improve existing business processes and ensure compliance with regulations.
Provide a summary describing the overall purpose of the position. Utilizes working knowledge of QSR/ISO regulations and their current interpretations in training as well as planning, conducting and leading audits of the internal Quality System. Evaluates and communicates the compliance and adequacy of those systems with required regulations. Acts as a consultant in regulatory and quality systems requirements. Interfaces with all level of management in the organization. Interfaces with individuals at all levels of the organization and all areas of the company included in the Quality System, or impacted by regulatory requirements. Acts as a source expert/regulatory consultant for domestic and international regulations. Manages audit teams, review of report findings, and follows up for closure of findings. Writes reports of audit results to responsible management and leads and conducts pre- and post-audit conferences with responsible management. Schedules, oversees and conducts follow-up audits of corrective actions to previous audit findings. Specific Duties: Prepares for and leads audits of the Quality System. Develops audit schedule, prioritizes audits, and developes audit procedures. Develops audit protocols and checklists. Interfaces with the staff in all plant sites to resolve issues relative to QSR/ISO compliance. Reviews and implements appropriate regulations into audit and training programs. Leads the development of training materials and trains functional area personnel on conducting self-audits. Evaluates and approves documents within the BCCR system as required. Qualifications " Bachelor's degree or master's degree in engineering, chemistry, microbiology, or other scientific field. Certificate of Completion of a Lead Auditor course, RAPs certified Lead assessor or ASQC certified Quality Auditor desired. Extensive audit experience in medical device industry is desired. Experience or Equivalent: Minimum required to perform job. 5+ years experience as auditor in a QSR and ISO 13485-regulated environment; or equivalent combination of education and experience. Knowledge, Skills, and Abilities Requirements: List unique knowledge, skills, or problem-solving requirements. Strong decision-making skills are necessary in identifying deficiencies in quality systems and business operations which result in recognition of improvement opportunities which will impact the overall effectiveness of the quality systems Cardinal Health offers a competitive compensation and benefits package including 401K and tuition reimbursement. Successful candidates must pass a background check and drug screen. We are an Equal Opportunity Employer M/F/D/V - Diversity Works Here " To apply for this position please sent your resume to Rick Berlin at rick.berlin@cardinal.com
Sr. Regulatory Affairs Specialist JOB SUMMARY Develops regulatory strategy. Develops and maintains domestic submissions. Assists in the development and maintenance of international regula | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
