2nd Shift Quality Assurance Engineer

Our client, a Global Medical Device Manufacture has an immediate opening for a Quality Assurance Engineer for a 12 Month + Contract . Our client offers results-driven people a place where they can make a difference – every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

40 hour work week – Shift 1 : 30pm to 11 : 30pm (Monday – Thursday and flex on Fridays if needed)

Requirements

• Work closely with Operations and the business functions to ensure quality performance of product and processes.

Non-Conformances

o 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 Activities

o 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 approval

o 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 / Validation

Qualifications