We’re currently recruiting for an exciting opportunity with an award winning medical device organization based in Cork. 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.
• Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
• Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO).
• Understand supplier performance metrics and what they mean to the business
• Promote continuous improvement and Process Excellence activities within the Global Supply Chain
• Resolve problems & eliminate constraints to ensure project and supply targets are met.
• Identify requirement to transfer identified products to alternate supplier or obsolete product
• Execute product equivalency assessments
• Perform QIR and system updates
• Create spec and drawing approvals
• Lead PVE with responsibility for associated documentation
• Escalate timeline risk with mitigation recommendations
• Collaboration with internal cross-functional team members and suppliers on timeline execution for SQE responsibilities
• Liaise with internal stakeholders to ensure any supplier-based decisions are understood and accepted at site level
Education & Experience
• A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline.
• A minimum of 6 years of experience in a highly regulated industry is required.
• Experience in the Medical Device industry and/or Pharmaceutical industry is required.
• FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required.
• Experience in root cause analysis is required.
• Six Sigma, Lean, or ASQ Certification and trainings an asset.
• This position will require some UK based travel
If you would like further Information you can contact the recruiter directly:
Sean McCarthy | Tel: +353 (0) 87 798 8480