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Quality Engineer III, Specialty

Company: Thermo Fisher Scientific
Location: fremont
Posted on: May 3, 2021

Job Description:

Position Summary:Provide oversight and subject matter expertise in handling change orders, complaints, non-conformances, CAPAs, variances in accordance with site specific and corporate procedures as well as current US FDA and international regulations.Review, evaluate, and investigate product and process non-conformances relative to the identity, quality, safety, and effectiveness of medical products.Identify, generate and publish metrics and reports related to the change orders, complaints, non-conformances, CAPAs, variances issues.Follow-up internally and externally to assure compliant, complete, and accurate files for change orders, complaints, non-conformances, CAPAs, variances, and product performance information.Support change orders, complaints, non-conformances, CAPAs, variances in internal and external audits and inspections.Major Responsibilities:Ensure records (e.g., completion of investigations, risk assessment, review and/ or creation of documentation) associated with change orders, complaints, non-conformances, CAPAs, variances are adequate, accurate, detailed and timely.Collaborate with appropriate Technical, Clinical, Field/Sales, Operations and R resources to ensure assigned tasks are completed on time.Provide guidance to personnel to complete tasks compliantly, correctly, and timely, where the incumbent is accountable for the task.Analyze and report data using spreadsheets, graphs, and databases.Elevate issues to management as appropriate.Drive continuous improvement of the Quality System.Perform other duties as requiredMinimum Requirements/Qualifications: Bachelors' degree or relevant experience with an Associate's degree in clinical/medical discipline, engineering or science.5 - 7 years related experience in a regulated environment; preferable with medical devices or pharma.Knowledge of applicable international regulations and standards (CFR, IVDR, QSR, ISO 13485, ISO 14791, etc.).Medical device experience is a must.Non-Conformance and CAPA investigation experience is a plus.Regulatory and Quality Management knowledge and skills.Must have excellent customer service skills, an analytical mind and the ability to evaluate and disseminate information from a global perspective.Previous experience in legal, technical or medically related area preferred.Must have demonstrated ability to think strategically and be able to prioritize multiple tasks.Self-motivated and is able to work with little guidance for routine tasksDemonstrated ability to manage multiple activities and tasks.Demonstrated use of quality tools methodologies and strong computer skills.

Keywords: Thermo Fisher Scientific, Fremont , Quality Engineer III, Specialty, Other , fremont, California

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