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Senior Med Device QA Engineer

1 month ago

Redmond WA United States Joulé Full time

Job Title: Senior Med Device QA Engineer

Increase your chances of an interview by reading the following overview of this role before making an application.
Location: Redmond, WA
Hours/Schedule: Mon- Fri 8am- 5pm
Compensation: $36.00- $46.66
Type: Contract

Overview
Global Medical Device company looking to hire experienced QA Engineers to join their growing team This is not an IT role. IT backgrounds will not be considered

Responsibilities 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.

Requirements Multi-tasking, strong communication, problem solving
Bachelor's degree in a Science/technical field or a related field
1-3 years of experience

Benefits
System One offers 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.