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
Quality System Specialist in workfromhome at Unknown Company
This position is listed as full time and able to be worked remotely.