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Senior Source Quality Engineer

Reference:SMC9978 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: EHS Engineer, Quality Engineer

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.
• Supplier Development including Robust process implementation and Inspection Readiness.
• Change control management and qualification of supplier process changes and supplier
transfers programs.
• Supplier Process validation and approval in line with internal and Regulatory requirements.
• 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).
• Promote continuous improvement and Process Excellence activities within the Global Supply
• Resolve problems & eliminate constraints to ensure project and supply targets are met.
• Work with the Sourcing teams to ensure the supply base is optimized to reflect the most
efficient processes;
o Identify requirement to transfer identified products to alternate supplier or obsolete
o Execute product equivalency assessments.
o Lead PVE with responsibility for associated documentation.
o Escalate timeline risk with mitigation recommendations.
o Collaboration with internal cross-functional team members and suppliers on timeline
execution for SQE responsibilities.
o Liaise with internal stakeholders to ensure any supplier-based decisions are understood
and accepted at site level.
• Connect – Interface with partners in Source, R&D Engineering, Manufacturing Engineering,
Receiving Inspection, Manufacturing Quality Engineering, Quality Systems and suppliers serving
multiple industries.
• Shape – Challenge critical thinking skills by solving supplier challenges, such as timely material
qualification/maintaining production yield, while simultaneously navigating quality system
requirements, engineering best practices, and supply chain demand.
• Lead – Take accountability for supplier qualification and performance by developing strong
relationships with supplier executive leaders to drive improvements throughout the value chain.
• Deliver – Manage deliverables in a fluid environment with varying levels of complexity while
maintaining alignment with multiple stakeholders Developmental

Education & Experience

• A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or
related discipline.
• 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.
• Six Sigma, Lean, or Lead auditor Certification and trainings an asset.
• This position may require some EU based travel.

If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480


Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.

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