Houston Metro Area, TX 77054 US
R&D Partners is seeking to hire a Quality Engineer II in Houston, TX.
Benefits of this role:
Benefits + 401k
Your main responsibilities as a Quality Engineer II:
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.
What we are looking for in a Quality Engineer II:
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
Why Choose R&D Partners?
Refer a Friend bonus
R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal opportunity employer.