Contract position: Large medical device manufacturer has a need for Sr Quality Engineer in Round Lake IL to perform general quality engineering support for the plant. This is a contract position expected to last 6 months, could be longer based on performance, possible temp to hire. Great Contractor Benefits! Apply Now! Will hire ASAP!
Responsibilities for the Quality Engineer
- Evaluate complaints to determine if CAPA is needed
- Perform validation assessments
- Assist in identifying the appropriate actions to mitigate or eliminate the root causes, and in determining an Effectiveness Plan for the actions (including effectiveness criteria and timeframe).
Requirements for the Quality Engineer
- Bachelor's degree in Engineering or Science
- 3+ years of experience managing complaints, CAPA, and Change Control within the medical device pr pharma industry
- Knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820 and 211) and understanding of regulations governing markets outside the U.S. preferred
- 2+ years direct quality experience with ISO 13485
- Excel experience
- Trackwise experience is a plus
- Paid Vacation
- Health Insurance, and more...