Senior Quality Assurance Engineer
Location: Redmond, WA Job Type: Contract – 12 Months Pay Rate: $70–$73/hour Work Arrangement: Hybrid – 4 days onsite, 1 day remote (remote day available after completion of training) Position Overview We are seeking an experienced Senior Quality Assurance Engineer to support manufacturing operations and supplier quality activities within a fast-paced, regulated manufacturing environment. This role will play a key part in maintaining product and process quality by investigating nonconformances, managing corrective and preventive actions (CAPAs), conducting root cause analysis, and driving continuous improvement initiatives. The ideal candidate is a proactive problem-solver who can independently manage multiple quality issues, lead cross-functional discussions, and work with urgency to resolve manufacturing and supplier-related challenges.
Key Responsibilities
Quality Systems & Nonconformance Management Own and manage internal and supplier-related Nonconformance (NC) and Corrective and Preventive Action (CAPA) records, ensuring timely investigation, documentation, and closure within TrackWise. Lead root cause investigations and coordinate corrective actions with cross-functional teams and suppliers. Investigate and disposition nonconforming products through the Material Review Board (MRB) process. Support manufacturing-related complaint investigations and product field actions. Lead problem-solving discussions and coordinate containment activities, particularly during production disruptions or line-down situations. Supplier Quality Management Partner with suppliers to investigate quality issues and drive resolution, escalating Supplier Corrective Action Requests (SCARs) when necessary. Review and manage Supplier Initiated Change Requests (SICRs), coordinating cross-functional assessments and approvals. Evaluate supplier changes and oversee Production Part Approval Process (PPAP) activities. Support manufacturing transfers between facilities and identify opportunities for supplier part certification. Process Improvement & Validation Support continuous improvement initiatives focused on manufacturing efficiency, product quality, and production throughput. Review and support process and equipment validation and qualification activities, including Measurement System Analysis (MSA). Evaluate internal and supplier-proposed process changes and assess their potential impact on product quality. Review validation protocols, reports, procedures, work instructions, change orders, and other quality documentation. Maintain and analyze quality performance metrics and KPIs, identifying trends and implementing appropriate improvement actions. Participate in the development and revision of quality procedures and manufacturing processes.
Required Qualifications
Bachelor's degree in Engineering or a related scientific discipline. Minimum of 3 years of quality engineering or quality assurance experience in a manufacturing or regulated environment. Strong experience with root cause analysis, nonconformance investigations, and corrective/preventive actions. Experience collaborating with cross-functional teams to resolve manufacturing and supplier quality issues. Ability to independently manage multiple priorities in a fast-paced, time-sensitive environment. Excellent communication, organizational, analytical, and problem-solving skills.
Preferred Qualifications
Experience in the medical device industry or another highly regulated manufacturing environment. Manufacturing floor experience and familiarity with production operations. Experience with process and equipment validation, qualification, and validation documentation. Familiarity with PPAP, SCAR, DFMEA, PFMEA, Control Plans, and Process Flow Diagrams. Experience reviewing supplier changes and assessing quality and validation requirements. Knowledge of quality management systems and document control processes. Experience with TrackWise, MasterControl, and SAP. Work Schedule & Environment First shift. Typically 7:30 AM to 5:00–6:00 PM, with flexibility depending on business and production needs. Four days onsite and one remote day per week. Remote work will be available after completion of initial training. Frequent interaction with manufacturing operators, engineering, regulatory, compliance, and supplier teams. Fast-paced manufacturing environment requiring flexibility, sound judgment, and the ability to respond quickly to emerging quality issues.