Senior Quality Assurance Engineer

  • Location: Washington, United States
  • Type: Contract
  • Job ID: 10252
  • Work Setting: On-Site
  • Posted: April 14, 2026
  • Closing Date: April 26, 2027
  • Tax Status: W2
Senior Quality Assurance Engineer
12-month Contract
On-site in Redmond, WA
Must be able to work on a W2
 
Requirements
  • Support manufacturing operations and suppliers
  • Work closely with Operations and cross-functional teams to ensure quality performance of products and processes
  • Investigate nonconformances, CAPAs, complaints, and product field actions
  • Own nonconformances (NCs) and CAPAs, including timely processing and closure within electronic systems
  • Perform root cause analysis and lead cross-functional problem-solving efforts
  • Contain and disposition nonconforming product, including participation in MRB activities
  • Support manufacturing operations during line-down situations in a fast-paced environment
  • Collaborate with internal teams and suppliers to resolve quality issues, including escalation of Supplier Corrective Action Requests (SCARs)
  • Execute and manage supplier change requests, including Supplier Initiated Change Requests (SICRs)
  • Own and support Production Part Approval Process (PPAP) activities for supplier changes
  • Support manufacturing transfers between facilities, executing required quality activities
  • Collaborate with stakeholders to support supplier part certification activities
  • Drive process improvements across manufacturing and distribution processes
  • Participate in and support validation activities, including process and equipment validation and qualification, and Measurement System Analysis (MSA)
  • Review and/or support validation protocols and reports
  • Perform label reviews, change orders, and documentation reviews
  • Participate in the creation and/or review of new or modified procedures
  • Maintain and analyze KPIs related to product and process quality, identifying trends and driving appropriate actions
  • Interact frequently with manufacturing operators, engineering, regulatory, compliance, and suppliers
  • Perform other related duties as assigned
Qualifications
  • Naturally curious and investigative mindset
  • Strong root cause analysis experience
  • Comfortable leading discussions and influencing stakeholders
  • Ability to work independently and collaboratively
  • Strong communication skills, including explaining resolution plans
  • Ability to work in fast-paced, high-pressure, time-sensitive environments
  • Experience working in a manufacturing environment (highly desirable, not required)
  • Experience in a regulated industry
  • Medical device experience (preferred, not required)
  • Engineering or science degree (BS preferred)
  • Experience with TrackWise, MasterControl, and SAP (SAP experience helpful but trainable)
  • Familiarity with quality tools and concepts such as PPAP, validation, DFMEA/PFMEA, control plans, process flow diagrams, and MSA
  • Ability to define requirements and collect objective evidence
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