Quality Engineer II

Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work. Identifies and resolves complex exceptions to work assignments. Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings. Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product. Participates in Customer Complaints investigation for areas under their control. Continually seeks to drive improvements in product and process quality. Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions. Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints. Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects. Knowledgeable on Risk Management , BSEN 14971 requirements. Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes. May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements. Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality. Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff. Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives. Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise. Is familiar with the internal auditing process A Level 8 Degree (240 Credits) or equivalent in an Engineering or Science related discipline. A minimum of 3-4 years experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment. Familiar with Internal Audit Processes. Team player and someone who is fully motivated to achieve and demonstrate best practices in line with the department and site objectives. Experience in Extrusions & Mouldings is desirable.