- Location: Illinois, United States
- Type: Contract To Hire
- Job ID: 10538
- Work Setting: Off-Site
- Posted: August 13, 2026
- Closing Date: March 19, 2027
- Tax Status: W2
Senior Quality Assurance Engineer – Medical Devices (Contract to Hire)
Location: Remote
Hours: 20–30 hours/week (Contract)
Senior Quality Assurance Engineer to support medical device clients across the full product lifecycle. This is an opportunity to join a growing consulting firm where your expertise will directly influence client success and company growth.
Responsibilities:
- Implement and improve FDA QMSR/ISO 13485 Quality Systems
- Lead Design Control activities and maintain Design History Files
- Develop Risk Management documentation (ISO 14971)
- Create Design Traceability Matrices
- Conduct supplier qualification and quality audits (desk and on-site)
- Lead CAPA, nonconformance, and continuous improvement initiatives
- Support manufacturing quality and Design Transfer
- Participate in Design Reviews and Post-Market Surveillance
- Support FDA and EU MDR regulatory activities
- Build strong client relationships and serve as a trusted quality advisor
- Support FDA and EU MDR regulatory activities, with the opportunity to expand Regulatory Affairs knowledge and responsibilities over time
- Bachelor’s degree in Engineering or related field
- 5+ years in medical device Quality Assurance
- Strong knowledge of FDA QMSR, 21 CFR Part 820, ISO 13485, and ISO 14971
- Experience implementing Quality Management Systems
- Excellent communication and technical writing skills
- ASQ CQA or CMDA certification strongly preferred
A self-directed leader with strong technical skills, excellent judgment, adaptability, intellectual curiosity, and a passion for helping innovative medical technologies improve patient care. Someone who thrives in a fast-paced consulting environment, enjoys expanding their knowledge and capabilities, and is excited by the opportunity to potentially grow beyond Quality Assurance into broader Regulatory Affairs responsibilities.