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 current 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 environment, 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 Dia

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