Collins McNicholas

Role Responsibilities:

  • Ownership for supplier quality performance and measurement including KPI’s and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
  • Support quality issues with suppliers & partner with Internal Customers; Support effective supplier containment and corrections/corrective actions
  • Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
  • Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
  • Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes
  • Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders
  • Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
  • Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
  • Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
  • Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions
  • Deliver continuous improvement activities focusing on supplier quality
  • Participate as required with key stakeholders
  • Participate in supplier reviews for assigned suppliers as required
  • Participate in cross functional projects both locally & globally as required

 

Role Requirements:

 

  • Bachelor’s Degree in Engineering/Science/
  • Minimum of 1 years’ experience in manufacturing environment or equivalent.
  • Good knowledge with GMP, ISO 13485, 21 CFR Part 820 standards
  • Good knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment
  • Demonstrated working knowledge to positively influence supplier quality performance
  • Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions
  • Internal Quality Auditor Qualification either in AS 9100 or ISO13485, CFR820 or comparable industry standards and regulatory requirements

 

Personal Skills Required:

  • Ability to plan, organize and implement multiple concurrent tasks
  • Strong communication/ influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.
  • Demonstrated ability to work in cross-functional team environments
  • Willing to travel in support of business needs to different geographical locations
  • Good knowledge of continuous improvement methodologies
  • Basic understanding of manufacturing processes
  • Mobility to international assignments
  • Basic understanding of project management

 

 

For a confidential discussion and more information on the role, please contact Eloisa Ruiz on 021 4809118 or email eloisa.ruiz@collinsmcnicholas.ie

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