Cache of job #13525520

Job Title

Supplier Quality Compliance Engineer

Employer

CPL

Location

Limerick

Description

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 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. Professional Requirements- Required: Bachelor’s Degree in Engineering or Science fields. Minimum of 2 years experience in manufacturing environment or equivelant . 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. This job originally appeared on RecruitIreland.com.

Date Added

2799 days ago

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