What are the responsibilities and job description for the Senior Quality Assurance Engineer position at GForce Life Sciences?
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