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Sr. Quality Assurance Engineer (Medical Device)
$ 65.00 - $ 70.00
Posted 09/28/2026
Contract
Contract
Job ID:
27633
Job 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 Redmond, WA
Discover exciting job opportunities in the vibrant Redmond, Washington area! Nestled in the scenic Pacific Northwest, Redmond offers job seekers a unique blend of tech innovation, outdoor recreation, and cultural charm. Known as the "Bicycle Capital of the Northwest," Redmond boasts an extensive network of bike trails perfect for exploring the stunning Cascade Mountains. With nearby attractions like the iconic Space Needle in Seattle, the picturesque wineries in Woodinville, and the world-renowned Museum of Glass in Tacoma, there's no shortage of adventures to be had. Whether you're drawn to the bustling tech scene with companies like Microsoft and Nintendo, or craving a taste of the local cuisine at the Food Truck Roundup, Redmond has something for everyone. Join us in experiencing the dynamic opportunities and endless possibilities that await in this thriving region!
