We’re currently recruiting for an exciting opportunity with an award-winning 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.
At our Sterilization Validation Department, we focus on product quality excellence and providing exemplary service to the businesses & Operating Units we support. Our Quality Engineers anticipate and respond to changing sterility requirements, provide strategic leadership to influence the global sterility environment to benefit the patients we serve and are directly involved in building the organization in support of Sterility Assurance assessments for New Product Development and Site Transfers
• Support sterility assurance activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites
• Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation
• Support cross functional teams in design protocols to ensure that new products/ product changes are adequately evaluated/tested to guarantee compliance to all regulatory standards.
• Deliver on projects assigned and works with other stakeholders to achieve desired results within defined timeframes
• Support your projects in internal and external audits and in submission preparation, addressing any questions regarding these submissions
• Perform calculations, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements.
• Review systems and processes for optimization and troubleshooting.
• Adhere to all relevant site wide procedures and practices for Safety & GMP
Education & Experience
• Degree (Level 8) qualification in relevant technical discipline e.g Science or Engineering
• 2-3 years’ experience with Sterilisation Validation is desirable
• Excellent understanding of GMP and documentation required
• Dynamic team player with good communication skills
• Can work effectively and proactively as an individual or on cross functional team.