Supplier Quality Compliance Engineer

Careerwise Recruitment

Limerick

SUPPLIER QUALITY COMPLIANCE ENGINEER required by CareerWise Recruitment for our medical device client in Limerick. Our client is a multinational medical device manufacturer in Limerick. The SUPPLIER QUALITY COMPLIANCE ENGINEER serves as a liaison between suppliers and our client to drive effective continuous improvement as a result of the supplier base. You will work with internal customers and suppliers in support of supplier quality issues; provide technical support for activities related to supplier quality system assessment and performance evaluation. THE ROLE: * 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. * 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 in SCRB in conjunction with key stakeholders. * Support assessment of supplier changes. * Participate in supplier audit program - planning, execution and closure. * Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers. REQUIREMENTS: * Bachelor's Degree in Engineering or Science fields. * Minimum of 2 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. * 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. This job originally appeared on RecruitIreland.com.

2654 days ago