Sign upLog in
Engineering Jobs
iMPact Business Group, Inc. logo

Sr. Quality Assurance Engineer (Medical Device)

iMPact Business Group, Inc.

  • Redmond, WA
  • 28 days ago

    Highlights

    This opportunity is ideal for a quality professional with strong manufacturing experience who can drive non-conformance investigations, CAPA activities, supplier quality initiatives, and process improvements within a highly regulated environment. Own internal and supplier-driven Non-Conformances (NCs) and CAPAs , including timely processing and closure within TrackWise.

    Numbers & Facts

    LocationRedmond, WA
    IndustryStaffing/Employment Agencies
    Company Size100 to 499 employees
    Year Founded2004
    Websitehttps://impactbusinessgroup.com

    Description

    18-Month+ Contract | 40 Hours/Week | Monday–Thursday, 7:30 AM–5:00/6:00 PM | Friday Flex as Needed | Potential 1 Remote Day/Week

    Our client, a global leader in the medical device industry, has an immediate opening for a Quality Assurance Engineer for an 18-month+ contract. This opportunity is ideal for a quality professional with strong manufacturing experience who can drive non-conformance investigations, CAPA activities, supplier quality initiatives, and process improvements within a highly regulated environment.

    Key Focus
    • Non-Conformances (NC) and CAPA
    • Supplier Quality and Corrective Actions
    • Manufacturing and Process Quality
    • PPAP and Change Management
    • Process and Equipment Validation
    • Medical Device Quality Systems

    What You'll Do
    • Partner with Operations and cross-functional teams to ensure product and process quality performance.
    • Own internal and supplier-driven Non-Conformances (NCs) and CAPAs, including timely processing and closure within TrackWise.
    • Investigate and disposition non-conforming product through the Material Review Board (MRB) process.
    • Support manufacturing-related complaint investigations and product field actions.
    • Collaborate with suppliers to resolve quality issues and initiate Supplier Corrective Action Requests (SCARs) when required.
    • Manage Supplier Initiated Change Requests (SICRs) and coordinate cross-functional assessment and approval.
    • Support manufacturing transfers between plants and facilities.
    • Identify and execute opportunities for supplier part certification.
    • Support improvements to internal manufacturing and distribution processes.
    • Assess internal and supplier-proposed changes, including Production Part Approval Process (PPAP) activities.
    • Participate in the creation and review of new or modified quality procedures.
    • Support process and equipment validation, qualification, and Measurement System Analysis (MSA).
    • Maintain quality KPIs, analyze trends, and initiate appropriate corrective actions.

    What We're Looking For
    • Bachelor's degree in a science or technical field.
    • Minimum 3 years of quality experience, including operations or manufacturing experience.
    • Hands-on CAPA and Non-Conformance experience.
    • Experience with SAP or other ERP systems.
    • TrackWise experience is highly preferred.
    • Strong understanding of quality concepts including Risk Management, CAPA, Audits, Statistics, DMAIC, and DFSS.
    • CQE, Lean Six Sigma Green Belt (LSSGB), or Lean Six Sigma Black Belt (LSSBB) certification preferred.
    • Medical device industry experience preferred.
    • Familiarity with ISO 13485, GDP, GMP, and U.S. and international medical device regulations preferred.
    • Experience working with regulatory agencies such as the FDA, MoH, or TÜV is a plus.
     


    About Company

    Working with iMPact

     

    Here at iMPact we have helped connect candidates to opportunities available in Information Technology, Accounting/Finance, Engineering, and Business Process/Administration. We have full-time, part-time and contract positions available in Michigan, Florida as well as nationwide.

     

    Our headquarters is located in Grand Rapids, MI and we also have an office in Tampa, FL. When you’re working with us, one of our experienced recruiters will connect you with matching opportunities and they will be there every step of the way to help you through the application, interviewing and onboarding process to ensure success.

     

    To connect with one of our recruiters, submit your application for one of our open positions, or visit our website www.impactbusinessgroup.com to submit your resume for general consideration. We look forward to hearing from you!

    Similar Job Searches

    Systems Engineer Jobs in Redmond, WADesign Engineer Jobs in Redmond, WAService Engineer Jobs in Redmond, WAApplications Engineer Jobs in Redmond, WAPlanning Engineer Jobs in Redmond, WAProduct Engineer Jobs in Redmond, WAQuality Engineer Jobs in Kirkland, WAQuality Engineer Jobs in Bothell, WAQuality Engineer Jobs in Bellevue, WAQuality Engineer Jobs in Seattle, WA

    Similar Jobs

    See more jobs