Quality System Specialist
Job Summary
Detail-oriented and experienced in regulated environments, the full-time temporary Life Sciences Quality System Specialist will support documentation remediation and compliance initiatives for medical device products while working remotely.
Key responsibilities
- Support completion of IVDR documentation remediation activities for legacy products within established project timelines
- Review, reconcile, and organize legacy Design History Files (DHF), technical files, and risk management records
- Coordinate with cross-functional teams to ensure documentation accuracy and completeness
Required qualifications
- Bachelor's degree in life sciences, engineering, quality, regulatory affairs, or a related technical discipline preferred, or equivalent experience
- 2+ years of experience in a regulated quality, design control, or technical documentation environment
- Working knowledge of quality system requirements such as ISO 13485, FDA 21 CFR 820, or similar standards
- Experience with design history, technical file, or risk management documentation
- Proficiency with Microsoft Office applications; experience with eQMS platforms is preferred
Complete Job Description
The complete job description is available to members. Premium membership includes:
Full access to 44,387 remote jobs from human-vetted companies, updated daily
Resume Builder - AI-powered tool to craft, enhance, and tailor your resume to a specific job
Twice-monthly live group coaching and the full Remote Career Center
20% member discount on Career Services
Backed by a 30-day money-back guarantee
Company Company Name
Headquarters Headquarters
Founded Founded
Website
BBB URL BBB URL
The company description is available to members. Go Premium for full access to every job and company profile in our remote jobs database, backed by a 30-day money-back guarantee.
