Abbott Senior Quality Assurance Engineer in Alameda, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Abbott Diabetes Care are looking for a Senior/Staff level Quality Engineer with a background in electro-mechanical medical devices and strong experience in design control and validation. This position is part of our R&D QA group and reports into our Sr. Manager of Validation and Design Control.
Provide quality engineering expertise to investigate, audit, analyze, propose improvements and manage processes in the Quality Management Systems. Identify and implement initiatives for continuous improvement as appropriate for the design control system. Author, change and update QA procedures as applicable. Ensure compliance with all applicable Abbott Diabetes Care Quality Management policies and with all applicable regulatory and Abbott corporate requirements. (Such as, ISO 9001/13485 and FDA 21 CFR part 820, and IVD/MDD directives). Serve as primary representative for quality assurance functions for each Product Development Team assigned. Ensure each quality function is brought into the Project Team at the appropriate phase and is represented at Phase Reviews. Create and Implement Quality Plan for each new product development project, ensuring clear translation of requirements from DHF to DMR to DHR. Evaluate complaints, CAPAs, internal audits findings, customer audits findings and propose corrective and preventive actions. Analyze, monitor and report status and issues to upper management on design control related projects. Develop and implement Verification and Validation policies, status reports, and strategies, including maintenance of site Validation Master Plans. Review and approve validation protocols/reports. Build and maintain successful cross-functional relationships with internal department such as R&D, Engineering, Manufacturing, Operations, Quality Control and Regulatory Affairs. 1.Actively engage Operations and Engineering to implement design control project deliverables. 2.Drive compliance to and Maintain DMR/DHF requirements in accordance with project time line and design control requirements. 3.Responsible for the development, approval, and change control of, quality assurance procedures and design history documentation (e.g. Design Inputs, Design Outputs, Trace Matrix, Design Verification/Validation, Change Impact Assessments, Quality Plans, Work Instructions, Protocols, Reports, FMEAs, etc.). 4.Collect and analyzes quality information/data from various quality systems and develop reports, make data driven recommendation/decisions, take appropriate action based on the trends, communicate/report activities and status as needed for senior management review. 5.Conduct or assist in systems/process/product failure mode and effects analysis and initiation of corrective and/or preventative action as it applies design control activities. 6.Evaluate complaints, CAPAs, internal audits findings, customer audits findings and propose corrective and preventive actions. Analyze, monitor and report status and issues to upper management on design control related projects.
BS in engineering or related field (Mechanical or Biomedical preferred). MBA a plus. The incumbent must be able to lead new product development teams in addressing the technical quality issues arising for complex new diabetes care related products. He/She must be able to understand the business side of the project deliverables to ensure a realistic quality/project strategy. Lean Six Sigma training and/or certification preferred.
7-10 years overall experience in Quality Assurance or Engineering; minimum 5 years experience in medical device manufacturing or pharmaceutical industries, minimum 3 years direct experience in Design Control. Working knowledge applicable regulations and standards such as FDA, QSR, ISO 13485, ISO 14197, MDD, & IVDD. Demonstrated written, oral, and interpersonal skills. Strong analytical skills, problem solving techniques and statistical application experience. Knowledge in the areas of Medical Device Design and Development, Design Controls, V&V activities, manufacturing practices, statistical techniques Experience with Class 2 and Class 3 devices, sterility assurance and packaging validation experience a plus Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).
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