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Senior Supplier Quality Engineer – Our client is offering a unique and exciting opportunity in the Mid- West to be part of Start-Up.
We are exclusively working with our client, a world-leading Medical Device company. If you have a passion for improving the lives of patients with structural heart disease, please read on.
Our Client is driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
We’re looking for a Senior Supplier Quality Engineer that can satisfy the following requirements;
- Audit, monitor, evaluate, report and improve supplier Quality system performance and provide technical support to suppliers
- Perform supplier evaluations including on-site audits to assess supplier capabilities, determine approval status, and verify corrective action
- Collect and add supplier information required for the Approved Supplier List
- Conduct component and product Quality testing for purposes of supplier and component qualification and improvement
- Identify and implement statistical engineering tools and techniques to evaluate supplier process capability and technical performance
- Evaluate supplier Quality systems, strategies and regulatory compliance via vendor audits
- Collect and analyze Quality metrics relating to Supplier Quality
- Identify and define correction actions and follow-up to ensure completeness and effectiveness
- Communicate supplier Quality risks to upper management while suggesting improvements and cost savings where possible
- Bachelors Science degree (Engineering or Science) is required with 4 years minimum experience in the medical device required, pharmaceutical industry experience may be considered
- Experience with class II and class III medical devices a plus
- Demonstrated ability to apply statistical Quality engineering tools in a supplier environment
- Working knowledge of International and Domestic FDA regulations
- Effective communication and conflict resolution skills
- Effective problem-solving techniques (i.e. Root Cause Analysis, FMEA process, Gage R&R, Validation activities, etc.)
- Conduct effective root cause investigations assessment of corrective action strategies and effectiveness as applied to NCR’s and SCAR’s
- Strong understanding of manufacturing processes (i.e. Injection Molding, Extrusion, and Machining)
- Thorough understanding of Risk Management principles
- Strong communication and organizational skills to effectively manage and get results with external suppliers
- Six Sigma Black Belt/Lean Manufacturing experience preferred
- Certified Quality Auditor
- Domestic and International Travel upwards of 25%
If you like what you have read thus far send your CV to email@example.com or for a confidential discussion, please call Michael on 061 512270.