Job Title

Location:Redmond, WASalary:$45.00 USD Hourly - $57.00 USD HourlyDescription:Our client is currently seeking a Senior Engineer, Quality Assurance Engineering for a 12 month + contract.Key Areas of Responsibility:Work closely with Operations and the business functions to ensure quality performance of product and processes.Non-Conformanceso 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 Activitieso 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 approvalo 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/Validationo 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 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 (preferred, not required) Experience in a regulated industry Engineering or science degree (BS preferred) Tools & Systems UsedTrackWise - 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 evidenceBy providing your phone number, you consent to: (1) receive automated text messages and calls from the Judge Group, Inc. and its affiliates (collectively "Judge") to such phone number regarding job opportunities, your job application, and for other related purposes. Message & data rates apply and message frequency may vary. Consistent with Judge's Privacy Policy, information obtained from your consent will not be shared with third parties for marketing/promotional purposes. Reply STOP to opt out of receiving telephone calls and text messages from Judge and HELP for help.Contact:This job and many more are available through The Judge Group. Please apply with us today!