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Quality Control Engineer - Medical Device

AppleOne
Salt Lake City, UT
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
This Quality Control Engineer Position Features:• Work for a world class medical company• Company is located in Salt Lake City• Opportunity for growth • Great Pay to $100KPosition Overview: The Quality Engineer is responsible for ensuring product and process conformity to requirements. Ensuring documentation in conformance to the Quality Management Systems and applicable standards and regulations.How you contribute:Provide quality engineering support for quality manufacturing•s design & development Perform investigations related to complaints and or serviceSupport design and engineering change processesPerform inspections (e.g. First Article Inspections DHR inspections) before and after product / process release • Support internal audit actvites and follow-up on nonconformities and other findings (e.g. through GA-actions or CAPA) with internal process owners and suppliers.Co-host external audits in concert with quality systems team for the companyPeriodic review of DHR and production records of both internal manufacturing facilities and critical contract manufacturersPerform process (re-)validations and QMS Software (re)validations as required.Review and approve documented product-nonconformities (NCRs) before closure. Verify segregation and blocking of NC product and verify that released for use or reworked materials/components meet all specifications. Bring CAPA worthy improvement forward to the cross functional teamsCollect quality data and trending data for Management Review and Post Market Surveillance: from complaints (complaint rates failure mode statistics)s in-production product-nonconformity records (NCR rates failure mode statistics)s and supplier deliveries (supplier NCR rates).Supports operations and supplier controls including supplier risk classifications qualifications approval/releases monitoring scorecards and periodic (re)evaluation.CAPA process: support QARA team to drive CAPA planning•s containment actions implementation and effectiveness checks with process owners. Perform inspections for containments verify and approve implementation of actions plan and perform effectiveness checksParticipate in process and product risk assessments (e.g. pFMEAs dFMEA) for existing and new product development projects and ensure implementation of documented risk megaton controls in product realization processes.Maintain awareness and culture for quality and compliance in the organizations at all levels of your interaction. Raise any (potential) concerns to your manager.Bring suggestions for preventive Acton to your manager.Work within policy•s strategy•s priorities and guidance of your managerParticipate in global and local project work streams to represent QA G (e.g. SAP projects Qualifications:University degree at Bachelor or Master level. A Technical/Engineering/Physics/Biomed degree is preferred.Minimum of 5 years Experience in QA Engineering in an GSO 13485 (preferred) or GSO 9001 certified organization.Experience in QA and any other functions covers: Productions Design Transfers Purchasing Controls Complaint Handlings Warehousing•s Design/Engineering changes Design controls.Experience with Risk Management (e.g. GSO 14971 or other industry standard) is preferred.Experience with (Medical Devices or other industry) Electrical Equipment and a basic understanding of related GEC product safety standards (e.g. Medical Devices GEC 60601-1 series) AppleOne is proud to be an Equal Opportunity Employer. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

AppleOne

Address

Salt Lake City, UT
USA

Industry

Manufacturing

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