Specialist, Document Management

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.

Qualifications:
- 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

Benefits:
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

Application instructions:
- None provided.