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Details

Supplier Quality Engineer


Reference:SMC035584 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Engineer, Supplier Quality Engineer

Summary

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.

Duties

• 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