What are the responsibilities and job description for the Supplier Quality Engineer position at Katalyst CRO?
Summary
The Supplier Quality engineer will work closely with our suppliers and purchasing group to resolve supplier issues and prevent their reoccurrence. Applies and maintains standards for manufacturing, quality, design, testing, and integration of materials into finished products. Works across all product groups to analyze non-conforming parts and processes, participate in nonconforming material disposition, arrange containment actions, corrective action requests, and perform supplier audits, as necessary. This role collaborates with a range of internal departments, external partners, suppliers, and customers utilizing excellent communication skills, and a passion for excellence, integrity, innovation, and success. Must be able to perform the essential duties and responsibilities with or without direct supervision.
Roles & Responsibilities
The Supplier Quality engineer will work closely with our suppliers and purchasing group to resolve supplier issues and prevent their reoccurrence. Applies and maintains standards for manufacturing, quality, design, testing, and integration of materials into finished products. Works across all product groups to analyze non-conforming parts and processes, participate in nonconforming material disposition, arrange containment actions, corrective action requests, and perform supplier audits, as necessary. This role collaborates with a range of internal departments, external partners, suppliers, and customers utilizing excellent communication skills, and a passion for excellence, integrity, innovation, and success. Must be able to perform the essential duties and responsibilities with or without direct supervision.
Roles & Responsibilities
- Bachelor's degree in an engineering discipline or equivalent experience required.
- 5 years of experience in Supply Chain and/or Quality Assurance engineering associated with Medical, Semiconductor, defense, or other high-tech electro-mechanical equipment manufacturing.
- Working knowledge of international standards such as ISO 9001:2015 or ISO 13485:2016. Certified auditor training a plus.
- Experience overseeing Material Review Board (MRB) investigations and dispositions.
- Experience with supplier interactions and feedback. Oversight of supplier corrective actions requests and their effective resolution.
- Experience with supplier scorecards, process control plans and verification/validation testing.
- Significant experience with 5 why cause and effect or other structured problem-solving techniques (8D, CAPA, SCAR) is required