We are looking for Quality / CAPA Engineer - Manufacturing for our client in Round Lake, IL
Job Title: Quality / CAPA Engineer - Manufacturing
Job Location: Round Lake, IL
Job Type: Contract ? 12 Months / Contract to Hire / Direct Hire
- Responsible for developing, implementing and evaluating optimal, manufacturing cost-effective projects.
- In addition to providing technical support and service to these areas, the incumbent may also perform the following functions: supervising, requisitioning, defining, initiating, specifying, documenting and training.
- Act independently with minimal supervision to conduct smaller approved projects. Expected to make suggestion on improvements based on recent technical knowledge.
- Able to contribute to cost estimating of major capital budget items and the spending of approved project funds.
- Contribute to the planning and execution of components of the development process, which apply to product revision or enhancement or a defined piece of a larger project.
- Ability to manage routine small projects without assistance.
- Demonstrated experience in Mitigating, identifying, and resolving manufacturing and test method issues (NCR/CAPA).
- Experience in root cause investigation for validation failures, manufacturing issues.
- Good understanding of medical device (21CFR 820 & ISO13485) regulatory standards and engineering applications
- Primary Skills:
- Production Engineering and Manufacturing Engineeringexperience.
- Process Validation (Medical Devices IQ,OQ,PQ)
- Strong communication and interpersonal skills
- Good Communication and interpersonal skills.