Specialist, Document Management

Job description

Serves as the Subject Matter Expert for documentation support activities including: document formatting, and change request review and approval facilitation. Responsibilities: Maintain controlled medical-device documentation in compliance with ISO 13485 and Good Documentation Practices (GDP), ensuring accurate entries, proper approvals, revision control, distribution, and archiving. Review batch records for completeness, accuracy, legibility, traceability, and compliance with approved procedures before product release. Required Education: High School diploma or equivalent; Preferred Education: Bachelor's Degree Preferred Experience: Knowledge and hands-on experience with Document Management Systems; Experience in detail-intensive and customer-focused environments; Excellent organizational skills, attention to detail, and strong oral and written communications skills; Word processing knowledge and experience with Microsoft Office products