Realeve, a medical device company is seeking an experienced Quality Engineer to assist in the development of the Quality Management System (QMS). The Quality Engineer position is responsible for coordinating and performing the daily activities of the QMS to meet U.S. FDA and international standard requirements.
Qualifications & Essential Requirements:
- Establish & implement quality requirements for all phases of product life cycle.
- Responsible for development of procedures and instructions to meet quality requirements.
- Responsible for all inspections and calibration of test & inspection equipment.
- Coordinate supplier management activities including sourcing and qualifying suppliers, maintaining the Approved Suppliers List (ASL) and associated files.
- Coordinate internal and supplier audits.
- Assists with contract manufacturers to support manufacturing process development, validation, and inspections.
- Responsible for the identification and processing of nonconformances (NC).
- Responsible for orrective/Preventive Action (CAPA) management from CAPA generation to implementation, verification of effectiveness, and closure.
- Assists on Risk Management and Design History Files.
Qualifications, Skills, and Experience:
- B.S in Quality Engineering and 2-5 years working in quality position, preferably medical device with clean room experience.
- Understanding of principles/practices and familiarization with ISO 13485, ISO 14971, and FDA’s Quality System Regulation per 21CFR Part 820.
- Microsoft Office competency.
- Must be able to work independently, multi-task, and support several tasks/projects simultaneously.
- Must demonstrate strong interpersonal, presentation, and teamwork skills.
Pay: $60,000.00 - $65,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Retirement plan
Experience:
- ISO 13485, ISO 14971 and FDA Quality System Regulation : 3 years (Preferred)
Location:
- Effingham, IL 62401 (Required)
Work Location: In person
