Sr. Quality Assurance Engineer (Medical Device)

40 hour work week – Shift 7:30am to 5/6:00pm (Monday – Thursday and flex on Fridays if needed).  Potentially, 1 remote day per week. 

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.

Qualifications 

• Bachelor's Degree in science/technical field. Minimum of 3 years of experience. Operations/Manufacturing Experience. 
• CAPA/NCs Experience.
• SAP/ERP Systems experience.  TrackWise a plus! 
• Strong quality background with CQE and/or LSSGB or LSSBB certification 
• Previous medical device industry experience desired with understanding of US and International Medical Device Regulations, familiarity with ISO 13485, GDP, GMP as well as experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) and in working in compliance risk situations. 
• Strong knowledge of and experience with key Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics, DMAIC, DFSS).