• Cork

Initial 12 month contract role

RESPONSIBILITIES:

  • Provide overall quality assurance leadership in the management of suppliers engaged in the production of company 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).
  • Project management – planning, scheduling, tracking and execution of project activities as part of supplier and part qualification.
  • 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:
  • Identify requirement to transfer identified products to alternate supplier or obsolete product.
  • Execute product equivalency assessments.
  • 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.
  • 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

Education, Experience and Skills:

  • A minimum of a level 8 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 are an asset.
  • This position may require some EU based travel

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