Job Description
Our client a leading Multinational Healthcare company now required an experienced Quality Engineer to lead & project manage quality service projects within a manufacturing environment, for our client based in Galway.
The successful candidate will lead investigations into customer complaints, to minimise recurring complaints and complete all associated documentation in a GMP environment.
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Responsibilities for Quality Specialist ? Manufacturing:
? 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.
Requirements of Quality Specialist - Manufacturing:
? Honours Bachelor?s Degree in; Sciences, Engineering or similar.
? 4+ years? experience in resolving customer complaints through leading investigations, in line with a Quality Management System.
? Strong experience in using problem solving tools, preferably six sigma or similar.
? Proven experience with Risk Management and Continuous Improvements.