NEW JOB OPENING
SENIOR QUALITY ASSURANCE ENGINEER
IN Redmond, WA, USA!

Required Education:

• Bachelor's degree in engineering



Required Experience/Skills:

• Project management

• Experience in working in a compliance risk situation

• Experience in interacting with regulatory agencies

• 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



Preferred Experience/Skills:

• Medical device experience (preferred, not required)

• Experience in a regulated industry

• PPAP (nice to have)

• Validation experience

• DFMEA / PFMEA

• Control Plans

• Process Flow Diagrams

• Ability to define requirements and collect objective evidence



Tools & Systems Used:

• TrackWise – nonconformances, CAPAs, complaints

• MasterControl – document management

• SAP – order management, holds, manufacturing systems (SAP experience helpful but trainable)



Senior Quality Engineer:

• Work closely with Operations and the 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.



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



Documentation & Validation Work The QE will review and/or support:

• Validation protocols and reports

• Process and equipment validation

• Label reviews

• Change orders

• Documentation reviews

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**