Med Device Quality Assurance Specialist
7 days ago
Job Title: Med Device Quality Assurance Specialist
Location: Redmond, WA
Estimated Salary: $45.00 - $60.00 per hour
Job Type: Contract
Overview:
We are seeking an experienced Med Device Quality Assurance Specialist to join our team in Redmond, WA. As a Senior QA Engineer - Medical Devices, you will work closely with Operations and the business functions to ensure quality performance of products and processes.
Responsibilities:
- Work closely with Operations and the business functions to ensure quality performance of product and processes.
- 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.
- 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.
- 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.
Requirements:
- Multi-tasking, strong communication, problem solving skills
- Bachelor's degree in a Science/technical field or a related field
- 1-3 years of experience
Benefits:
We offer eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
About System One:
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