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Senior Source Quality Engineer

Reference:SMC9604
Location: Cork
Qualification:Degree
Experience:5-7 Years
Job Type:Fixed Term Contract
Salary:Not Disclosed
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We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. The Senior Source Quality Engineer is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Travel Opportunities: EU based travel may be required.

Your duties:

  • Provide overall quality assurance leadership in the management of suppliers engaged in the
    production of products.
  • 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
    Chain
  • 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

What you need:

  • A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline.
  • A minimum of 5 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.
  • Six Sigma, Lean, or Lead auditor Certification and trainings an asset.



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