Quality EngineerWe'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.Key Responsibilities: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 MDR and QSR standards, constantly promoting awareness of best industry practices, making appropriate decisions daily 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 risk documentation linkage.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.Possesses excellent collaboration skillsGives technical guidance to relevant team members as requiredIs 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.Education & Experience:A Level 8 Honours Degree (240 Credits) in an Engineering or Science related discipline.A minimum of 5+ years' experience working at Engineering level, ideally within the Medical Device industry or another highly regulated environment.Familiar with Internal Audit Processes.Project Management experience is essential.