Senior Supplier Quality Engineer role at a world leading, medical manufacturing business.
A world leading, medical manufacturing business.
- 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
- Participate in supplier reviews for assigned suppliers as required
- Bachelor's Degree in Engineering or Science fields
- Minimum of 24 months background 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
- Preferred industries are medical device, aviation, aerospace, automotive and defense
Internal Quality Auditor Qualification either in AS 9100 or ISO13485,CFR820 or comparable industry standards and regulatory requirements
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