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
Requirements 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).
- Bachelor's degree in Engineering or Science
- 3+ years medical device experience, prefer aseptic filling experience
- 2+ years direct quality experience with ISO 13485
- 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
- Excellent Excel experience
- Trackwise experience is a plus
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.