Quality Engineer II
Athlone
€50-€55k per annum
€50-€55k per annum
Overview
At our Client's Manufacturing Facility, they focus on meeting customer and patient needs every day. The focus is on delivering the highest levels of quality products to our patients. They do this through the development and operation of manufacturing processes to the highest levels of efficiency and performance. Achieving their aims through people and high performing teams. There is a huge focus on the development of cutting-edge medical devices in Airway Management but also for other life enhancing applications. In this exciting role as Quality Engineer, you will directly support the strategic automation and capacity enhancement program.
Responsibilities
At our Client's Manufacturing Facility, they focus on meeting customer and patient needs every day. The focus is on delivering the highest levels of quality products to our patients. They do this through the development and operation of manufacturing processes to the highest levels of efficiency and performance. Achieving their aims through people and high performing teams. There is a huge focus on the development of cutting-edge medical devices in Airway Management but also for other life enhancing applications. In this exciting role as Quality Engineer, you will directly support the strategic automation and capacity enhancement program.
Responsibilities
- Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- Participate in preparing / critically reviewing/approving NCMRs/ CAPAs/ Investigations and validation activities, providing expert QA technical direction and solutions as appropriate.
- Ensures effective product control measures in the event of issues being noted.
- Establishes the quality and compliance requirements for new manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling, fabrication of tools and equipment.
- Interacts with internal and external stakeholders in the processing of all quality and compliance activities and documentation ensuring our right-first-time culture prevails.
- Leads quality compliance activities including structuring and writing of protocols and reports for design, FAT, SAT, IQ, OQ, PQs in compliance with FDA CFR 21 part 11 and other relevant parts.
- Level 8 or higher qualification in Mechanical, Polymer, Biomedical or related Engineering /Science discipline with a minimum of 3 years of relevant experience in a highly regulated environment.
- Requires broad knowledge of manufacturing processes and quality systems, techniques and practices typically gained through extensive experience and/or education.
- Working knowledge of Extrusion, Blow molding or Injection molding, Automation and robotics.
- Application of statistical and analytical methods such as SPC, SQC, and DOE.• Experience with DFA (Design for automation), GAMP5, Lean Sigma, Minitab.