Our client, a world-wide known medical device company requires a SQE for a permanent role in Cork. This job will involve working in partnership with the Global Supplier Network, you'll be involved in the ongoing support for the internal business units to address ongoing supplier quality issues, development of suppliers and ensuring that our external supply chain are capable of meeting expectations from a quality, service and cost perspective.
- Ownership for supplier quality performance and measurement including KPI?s and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews
- Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective action
- 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.
- 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
Education, Experience and Skills
- Bachelor?s Degree in Engineering or Science
- Minimum of 1 year 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
NOTE: TRAVEL IS REQUIRED
For further information please contact Cliona O?Malley on 091730022 / email@example.com
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