Medical Device Quality Engineer
6 days ago
AJR Enterprises, LLC is a leading contract manufacturer of superior medical devices and advanced manufacturing solutions within the medical device industry. Our headquarters and manufacturing facility are located at our 180,000 square foot facility in St. Charles, Illinois.
We are focused on delivering the highest quality products and providing exceptional customer satisfaction in the medical device industry.
Key Responsibilities- Ensure compliance with Quality Systems policies and regulations (ISO 13485 and FDA Part 820)
- Develop and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Conduct supplier audits and write supplier contracts
- Provide training in quality system activities/requirements
Requirements:
- A Bachelor's degree in science, engineering or equivalent
- 10 or more year's relevant experience
- At least 5 years' experience in medical device manufacturing
- Strong knowledge of Quality Systems policies and regulations (ISO 13485 and FDA Part 820) with a strong background in medical device quality assurance and processes
- Experience conducting supplier audits and writing supplier contracts.
- Familiarity with statistical analysis.
We offer competitive salaries and benefits packages, including health insurance, retirement plans, and paid time off.
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