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Contact Info
Jack Caffrey
Life Science

01 507 9279
[email protected]
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Details

Associate Quality Engineer


Reference:JSC00041491 Location: Galway
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Quality Engineer

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.

Duties

At our Sterilization Validation & Biocompatibility Services Department, we focus on product quality excellence and providing exemplary service to the business units we support. Our Quality Engineers are directly involved in building the organization in support of Sterility Assurance & Biocompatibility assessments for New Product Development and Site Transfers

• Support sterility assurance & biocompatibility 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




KEY SKILLS & EXPERIENCE

• Degree (Level 8) qualification in relevant technical discipline e.g Science or Engineering
• 2-3 years’ experience with Sterilisation Validation or Biocompatibility 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 teams
• Ready to apply our knowledge and know-how
• Rare in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right.