Senior Engineer, Quality Assurance Engineering

Quality Engineer

Develops and implements methods and procedures for process control, process improvement, testing and inspection to ensure that the products are free of flaws and function as designed. Analyzes reports and defective products to determine trends and recommend corrective actions. Collaborates with supplier representatives on quality problems, ensures that effective corrective actions are implemented and contributes to supplier quality improvement programs. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Job requires an understanding and application of procedures and concepts of own discipline. The job requires attention to detail in making evaluative judgements based on the analysis of factual information. This role requires an Engineering degree or equivalent and a minimum of 2 or more years experience.

Key Areas of Responsibility:

• Work closely with Operations and the business functions to ensure quality performance of product and processes.
• Non-Conformances
• Collaborate with Internal cross-functional and Supplier teams to address top quality issues.
• 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.
• Support execution and analysis of manufacturing related complaint investigations and product field actions.
• Investigate and disposition internal non-conforming product within MRB, issuing NCs as appropriate.
• Supplier Activities
• Communicate & collaborate with suppliers regarding non-conformances, escalating Supplier Corrective Action Requests (SCAR) as required.
• Execute and manage Supplier Initiated Change Requests (SICRs) received from suppliers, engaging with cross-function teams for assessment and approval.
• Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.
• Collaborate with appropriate stakeholders to identify and execute opportunities for supplier part certification.
• Process Improvements/Validation
• Engage in the development and improvement of the internal manufacturing and distribution processes for existing products.
• Perform critical assessments and qualifications of internal and supplier-proposed change management activities, including Production Part Approval Process (PPAP) activities for supplier changes.
• Participate in and potentially lead the creation and/or review of new or modified procedures.
• Support the development and review of process and equipment validation/qualification and MSA of internal processes.
• 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. This role requires the candidate to be on site 4 days a week.