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.

Job Duties:

• 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.

Minimum Requirements

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!


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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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