Quality Engineer II
- Location: Houston, TX
- Type: VMS
- Job #38679
Exciting Supplier Quality Engineering opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care
Quality Engineer II
The Supplier Quality Engineer is responsible for maintaining quality of Vendors and the components they supply for the manufacture of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, monitoring supplier performance, assisting Vendors with technical root cause investigations, and representing Quality in cross-functional projects.
• Working jointly with Receiving Inspection, Purchasing, MS&T, and Vendors to assess non-conforming material in a timely manner.
• Assisting Vendors with root cause analysis to determine the correct cause(s) of non-conformances and to ensure that effective corrective and preventative actions are implemented.
• Evaluating new Vendors for approval and monitoring approved Vendors against established KPIs.
• Working closely with MS&T to ensure thorough and effective validations/verifications are performed on new or updated products or manufacturing processes.
• Owning numerous non-conformance records (NCIs), investigating and completing the NCIs within the allowed timeframes.
• Utilizing product/manufacturing process knowledge to assess customer complaints for supplier related non-conformances, contacting the supplier where appropriate.
Bachelor’s degree in Engineering
2 years of relevant experience in a regulated industry (FDA environment preferred)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!