Med Device Quality Assurance Specialist

7 days ago


Redmond, Washington, United States System One Full time

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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