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Sr. Supplier Quality Engineer

Company: Acist Medical Systems
Location: Eden Prairie
Posted on: May 20, 2023

Job Description:

Position Summary:
The Senior Supplier Quality Engineer will provide supplier quality input and support for the manufacture and distribution of finished good medical devices. This role collaborates with the Product Quality and Supply Chain teams to identify areas of improvement in the supply chain and deliver results that improve product quality. Work collaboratively throughout the organization to promote product and supplier quality in manufacturing and ensure best practices and continuous improvement principles are utilized wherever possible. Strive to assure product and processes conform to defined performance and customer requirements as well as applicable quality system requirements and external standards associated with the products or processes.
Primary Duties & Responsibilities:
Supplier Quality:

  • Participate in and lead supplier evaluation, qualification and approval activities including audits.
  • Conduct statistical analysis of supplier-related nonconformance data for the identification of trends and coordinates the implementation of corrective actions.
  • Lead the Supplier Corrective Action Request (SCAR) program, interfacing directly with suppliers and ensuring timely and effective SCAR completion.
  • Participate in product development by supporting component supplier selection, evaluation and approval activities, including supplier audits.
  • Plan and conduct scheduled supplier audits to assess compliance with requirements, including assuring effective resolution of resulting findings.
  • Conduct ongoing measures of supplier quality performance, including quarterly Supplier scorecards, to monitor overall health of Suppliers and and initiate appropriate actions to continually improve supplier quality performance
  • Lead the monthly Material Review Board including data generation and analysis, meeting execution, and completion of any follow up activities.
  • Partner with supply chain to appropriately manage the Approved Supplier List, participate on the Supplier Review Board, and collaborate to establish and execute supply chain strategies.
  • Document, evaluate, and approve supplier changes through the Supplier Change Evaluation process.

    Receiving Inspection and Manufacturing Quality Assurance:

    • Lead a team of technicians responsible for quality assurance of medical device products.
    • Promote employee development and foster growth of employees through:

      • Performance Management
      • Training and Skills development
      • Continuous one-on-one feedback
      • Bi-annual appraisal of individual performance
      • Recognition and motivational techniques/tools to drive high levels of employee performance and engagement

      • Supervise incoming material inspection and release, NCMR generation and product dispositions, product DHR review and Quality Release of finished medical devices.
      • Assist in defining critical attributes and characteristics to be measured for components and products.
      • Provide engineering support for Inspection Plans, procedures, tools, and sampling methods
      • Define component qualification plans and approve first part review results.
      • Support continuous improvement of procedures and work instructions related to inspection or supplier controls.

Keywords: Acist Medical Systems, Eden Prairie , Sr. Supplier Quality Engineer, Professions , Eden Prairie, Minnesota

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