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
o Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
o 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.
o Support execution and analysis of manufacturing related complaint investigations and product field actions.
o Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
* Supplier Activities
o Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
o Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval
o Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
o Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
* Process Improvements/Validation
o Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.
o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
o Participate in and potentially lead the creation and/or review of new or modified procedures.
o Support the development and review of process and equipment validation/qualification and MSA of internal processes.
o 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 include:
* 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
* Frequent interaction with:
o Manufacturing operators (on the line and at their desk)
o Engineering
o Regulatory
o Compliance
o Suppliers
**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
* Label reviews
* Change orders
* 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
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.