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Staff Quality Assurance ScientistPosted by: Beckman Coulter
Posted date: Feb-15-2012
Location: Brea, California
This Staff Quality Assurance Scientist is part of the Development Quality Team and is responsible for design control and risk management for development projects prior to launching a new product or design changes.
The incumbent will be Core Team QA leads for various IVD system development projects and be responsible for reviewing/approving design requirement documents, design and development plan, regulatory strategy & test strategy, verification and validation plans, data and final reports to ensure design meets design inputs and user needs.
The incumbent will facility risk assessments for new designs and design changes at various project development phases or at various CAPA project phases including failure investigation, corrections, root cause analysis, corrective & preventive actions and effectiveness check.
· Provide scientific review of quality programs, which provide the basis for sound business and technical decisions.
· Consult with other departments on scientific processes, product and process improvement, and new product development.
· Provide key input to technical decisions by systems analysis of interacting affects of designs and processes.
· Prepare and issue assigned quality reports.
· Coordinate compliant management activities and recommend appropriate field actions to product regulatory committees.
· Determine and/or recommend direction taken in technical product or manufacturing issues.
· Recommend design, review and/or approve experiments. Review and/or comment on technical content of intra and interdepartmental reports.
· Provide design review and risk assessment expertise.
· Propose new methods or techniques for validation programs.
· Consult on OEM activities and internal/external audits.
· Provide input to specifications and product definitions.
· Give technical support on manufacturing and design issues.
· Advise on technical aspects of compliance regulations.
· Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criterion for obtaining results.
· Formulates/monitors project plans.
· May assign work to others (intra and interdepartmental) May be the key contact for outside application/technology providers.
· Leads process improvements.
· Leads training and guidance of technical staff.
· Adheres to policies and procedures. Exercises independent judgment in quality assurance related activities.
· Develops advance concepts, tests, and designs for complex issues.
· Recommends or terminates external resources(contractors).
· Initiates or recommends stop shipment actions.
· Expertise in the following areas is required for consideration:
· Strong technical background in areas of chemistry, biology, biochemistry, clinical chemistry, bioengineering or engineering;
· Knowledge in instrumentation including hardware and software, and system development;
· Strong skills in problem solving and in-depth data analysis on products and processes;
· Effectively communication skills to ensure positive outcomes across a multidisciplinary team;
· Experience in Multi-functional project leadership and/or people management;
· Experience in FDA/ISO Quality System and Risk Management;
· Experience in IVDD or Medical Device Verification and Validation &
· Product Submission/Registration;
· Experience in transferring new products from design to production;
· Strong technical writing skills.
· BS + 9 years industry experience/Relevant
· MS + 7 years industry experience/Relevant
· PhD + 4 years industry experience/Relevant
Apply online at:
https://recruiter.kenexa.com/bci/cc/CCJobDetailAction.ss? command=CCViewDetail&ccid=bupJEdUjsTs%3D &job_REQUISITION_NUMBER=97992
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Instruments for life science research are used by scientists as they study complex biological problems including the causes of disease, identify new therapies, and test new drugs. Our customers include hospitals, physicians' offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions. In fact, Beckman Coulter has more than 200,000 clinical and research instrument systems operating in laboratories around the world.