Biomedical Quality Engineer II
|Job Id: 19309|
|Job Type: Permanent|
|Industry: MEDICAL DEVICES|
|Worksite Location: Regional office|
|Location: York, SC 29745|
Join a leading global manufacturer of metals and materials. Their growth and success are made possible by their talented employees, R&D capabilities, values, vision, and technology-driven purpose.
- Tons of professional & personal growth
- Community and environmentally focus
- Great diverse company culture
They are seeking a talented and motivated Quality Engineer with GMP/GDP experience who is knowledgeable of pharmaceutical excipients and medical device manufacturing as well as ISO 13485 and FDA regulations.
In this newly created position, the Quality Engineer provides direct support to all functions in developing and maintaining Good Manufacturing Practices (GMP) / Good Documentation Practices (GDP) and compliance with practices in support of the company’s growing Long Term Implantable (LTI) product line.
THE RIGHT CANDIDATE WILL HAVE:
- Bachelor of Science degree in engineering or a related field
- American Society of Quality (ASQ) Quality Engineer certification, ISO 13485 internal auditor certification
- At least 5 years of experience working as a quality engineer in a biomedical, pharmaceutical, cosmetic, food or medical manufacturing environment.
- Working knowledge of GMP and GDP.
- Working knowledge of MS Office; advanced level of Excel experience
- Experience with Visio, Minita, and Sharepoint (or similar tools)
- Proven record using lean manufacturing tools to drive improvement
WHAT THEY OFFER THEIR EMPLOYEES:
- Attractive salary + bonus
- Comprehensive benefits package