What are the responsibilities and job description for the Quality Engineer position at Comrise?
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.
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.
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.
