Join a dynamic and forward-thinking organization at the forefront of medical device innovation. We are currently recruiting a skilled Quality Engineer to play a pivotal role in their exciting journey. They are currently embarking on a strategic automation and capacity enhancement program within the Patient Monitoring and Respiratory Interventions domains, this is your chance to be a key contributor to our ambitious plans for growth and impact.
• 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.
Key Skills & Experience
• Level 8 or higher qualification in Mechanical, Polymer, Biomedical or related Engineering /Science discipline with 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.
• A dynamic team player and problem solver who can work effectively on cross-functional teams.
Join our client's team to play a vital role in enhancing the quality, efficiency, and innovation of their medical device manufacturing operations.
For more information please contact Cathal Herron:
(090) 645 0660