We are working on an exciting Quality Engineer role for a large medical device client in Clonmel.
Note: no sponsorship is provided for this contract position, a valid working visa is required.
• Works on projects associated with line moves, equipment updates, CAPAs etc
• 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.
• 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.
• 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.
Qualifications:
• A Level 8 Degree or equivalent in an Engineering or Science related discipline.
• A minimum of 2- 3 years' experience working at Engineering level, ideally within the Medical Device industry.
• Previous Operations/Line Support within the medical device industry is a huge advantage.
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