We are seeking a Sr. QA Engineer (CAPA's and NC's, medial equipment manufacturing) to work on a team at our client site in Redmond, WA. Candidates requiring relocation will be considered, but please note that expenses are not covered. Pay Rate: $65.00 - $70.81 on a W2 with Roth Staffing (Ledgent Tech and Ultimate Staffing are divisions of Roth). Start/End Dates: 11/23/2026 - 11/22/2027 Key Areas of Responsibility

Work closely with Operations and th e business functions to ensure quality performance of product and processes. Non-Conformances

Collaborate with Internal cross-functional and Supplier teams to address top quality issues. Own identified internal and supplier-driven Non-Conformances (NC) and Corrective Action Preventative Action records (CAPA), managing the timely processing and closure of NC and CAPA records within the electronic management system, Trackwise. Support execution and analysis of manufacturing related complaint investigations and product field actions. Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.

Supplier Activities

Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required. Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities. Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.

Process Improvements/Validation

Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.



Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes. Participate in and potentially lead the creation and/or review of new or modified procedures. Support the development and review of process and equipment validation/qualification and MSA of internal processes. Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

Perform other related duties as assigned. Work Schedule & On‑Site Expectations

First shift On site 4 days/week, 1 remote day (remote day will come later following full training) Typical hours: 7:30 AM-5/6 PM No rigid schedule; flexibility based on workflow Role Overview

The Quality Engineer supports both: Manufacturing operations, and Suppliers. Key Responsibilities

Investigating nonconformances, CAPAs, and quality issues Performing root cause analysis Leading cross-functional problem-solving huddles Driving process improvements (efficiency, throughput, new equipment) This is a fast-paced, high-pressure setting, where multiple quality issues can arise at once. The QE must be able to pivot quickly, provide direction, and help get production back up and running. Key Skills & Traits Needed





Naturally curious and investigative Strong root cause analysis experience Comfortable leading discussions and influencing stakeholders Able to work independently and collaboratively Strong communication skills, especially when explaining resolution plans Comfortable working in stressful, time-sensitive situations Manufacturing & Stakeholder Interaction

Manufacturing operators (on the line and at their desk) Regulatory Compliance Experience on a manufacturing floor is highly desirable (but not required) Documentation & Validation Work The QE will review and/or support

Validation protocols and reports Process and equipment validation Documentation reviews The team has a broad scope of influence across quality systems and operations. Preferred (Not Required) Background

Medical device experience Experience in a regulated industry Required Background

Engineering or science degree (BS) Tools & Systems Used

TrackWise - nonconformances, CAPAs, complaints MasterControl - document management SAP - order management, holds, manufacturing systems (SAP experience helpful but trainable) Quality Tools & Concepts They Like to See

PPAP (nice to have) Validation experience DFMEA / PFMEA Control Plans Process Flow Diagrams Ability to define requirements and collect objective evidence Desired Skills and Experience

This would be a universal player conducting Quality Engineering based work. Their day to day will likely vary, depending on what is going on in the manufacturing space and business needs. They will own NCs and potentially CAPAs, needing to bring in cross functional teams, driving with urgency to resolve the issue. They will contain nonconforming product and work with the Oper

📌 Sr. Quality Engineer (Redmond)
🏢 Ledgent Technology
📍 Redmond