Our client is a leading medical technology company location nationwide. The Redmond division manufacturer' external defibrillators and emergency medical response products

50% market share of defibrillators sold to U.S. hospitals

85-90% market share in the U.S. advanced life support sector

Quality Engineer

Key Areas of Responsibility:

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

o Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.

o Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.

o Participate in and potentially lead the creation and/or review of new or modified procedures.

o Support the development and review of process and equipment validation/qualification and MSA of internal processes.

o Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessary.

• Perform other related duties as assigned.