Sr. Quality Assurance Engineer

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
                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.