We’re currently recruiting for an exciting opportunity with a Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Collaborate with the Project teams to facilitate the successful execution of the Design Services process and Commercialization of new products
• Experience with NCRs / CAPAs / SCAR
• Provide expertise in the areas of Quality Assurance, Design Controls, Risk Management, Statistical Techniques, and Regulatory Compliance and Submissions
• Lead and Support Design Services engineering activities (including but not limited to)
• New product introductions
• Development and approval of new product documentation.
• Qualification of new suppliers/ requalification of existing suppliers
• dFMEA , Risk management activities
• Test method development/validation activities
• Product / process validation protocol development and execution (IQ, OQ, PQ)
• Represent QA as part of the Material Review Board
• Perform Internal and Supplier Audits

• A degree in manufacturing engineering, quality engineering, life science or related field and experience within the Medical Device Industry or other highly regulated industry.
• Proven record of handling multiple tasks simultaneously and ability to manage project timelines