Senior Engineer, Quality Assurance Engineering

Our client is currently seeking a Senior Engineer, Quality Assurance Engineering

Job Title: Senior Engineer, Quality Assurance Engineering
Location: Redmond, WA 98052
Duration: 1+ Years


Position Summary

The Senior Quality Assurance Engineer will work closely with Operations and business functions to ensure product and process quality. This role involves investigating nonconformances, managing CAPAs, and driving supplier quality activities. The engineer will collaborate with cross-functional teams, lead root cause analysis, and support manufacturing complaint investigations and product field actions. They will also contribute to process improvements, validation activities, and supplier certifications, ensuring compliance with quality standards and operational efficiency.


Key Responsibilities

The engineer will own internal and supplier-driven nonconformances and CAPA records within TrackWise, ensuring timely closure. They will collaborate with suppliers on quality issues, escalate SCARs when required, and manage Supplier Initiated Change Requests (SICRs). The role includes supporting manufacturing transfers between facilities, executing PPAP activities for supplier changes, and reviewing or creating new procedures. The engineer will also support process and equipment validation, maintain KPIs, and interpret quality trends to recommend corrective actions.

Day-to-day activities will vary depending on manufacturing and business needs. The engineer will contain nonconforming product, lead cross-functional huddles, and drive urgent resolutions in fast-paced environments. They will also support documentation reviews, validation protocols, label reviews, and change orders.


Work Schedule & On-Site Expectations

This is a first-shift role requiring on-site presence four days per week, with one remote day. Typical hours are 7:30 AM to 5/6 PM.


Skills & Traits Needed

The ideal candidate is naturally curious, investigative, and experienced in root cause analysis. They should be comfortable leading discussions, influencing stakeholders, and working independently in stressful, time-sensitive situations. Strong communication skills are essential, particularly when explaining resolution plans.


Manufacturing & Stakeholder Interaction

The engineer will frequently interact with manufacturing operators, engineering, regulatory, compliance, and suppliers. Experience on a manufacturing floor is highly desirable, though not required.


Documentation & Validation Work

Responsibilities include reviewing validation protocols and reports, supporting process and equipment validation, and ensuring compliance in documentation reviews. The team has broad influence across quality systems and operations.


Preferred Background

Candidates with medical device or regulated industry experience are preferred. A bachelor's degree in engineering or science is required. Successful hires have come from bioscience or lab backgrounds, demonstrating strong technical thinking, stakeholder management, and execution speed.


Tools & Systems

The role requires proficiency with TrackWise for nonconformances and CAPAs, MasterControl for document management, and SAP for order and manufacturing systems. Experience with PPAP, validation, DFMEA/PFMEA, control plans, and process flow diagrams is valued.