Validation Engineer
• Location: Redmond, WA
• Type: W2 contract (NO C2C OR THIRD PARTY)
• Length: until 05/2026 (Contract extension expectation)
• Pay Rate – $40 - $51 hourly
• Work Authorization - Must be able to work in the U.S. with approved authorization status.
A strong candidate will also have:
- Education - BA Degree in Science/Technical field or related field
- Minimum of 3 years of experience
- CAPA Experience
- Systems - TrackWise/ERP Systems experience, MS Suite Experience
- Power BI knowledge a PLUS but not required
- Strong quality background with CQE and/or LSSGB or LSSBB certification
- Previous medical device industry experience desired with understanding of US and International Medical Device Regulations, familiarity with ISO 13485, GDP, GMP as well as experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) and in working in compliance risk situations.
- Strong computer literacy (Excel, Databases, ERP Systems, Trackwise, Statistical software packages, etc).
What You'll Do:
- Work closely with Operations and the 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.
Important information: To be immediately considered, please send an updated version of your resume to ...@kellyservices.com
*** (Kelly does not expense relocation/interview costs) **
In addition to working with the world's most recognized and trusted name in staffing, Kelly employees can expect:
• Competitive pay
• Paid holidays
• Year-end bonus program
• Recognition and incentive programs
• Access to continuing education via the Kelly Learning Center