Medical Device Documentation Specialist – On‑Site

Talentify; Maple Grove (MN); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Excellent benefits

Paid time off

Job summary

Actalent in Maple Grove, MN seeks a Documentation Specialist to manage day-to-day engineering documentation for investigational heart valve programs in an on-site role. You will create, maintain, review, and control documents, ensuring alignment with regulatory and quality requirements.

Work with Engineering, Quality, Regulatory, Manufacturing, and Clinical teams to assure DHF/DMR compliance, support audits, and drive process improvements using EDMS/PLM tools and Microsoft Office.

Qualifications

• 35 years of experience in document control or regulated environments.
• Experience with FDA Quality System Regulations and design control.
• Hands-on with EDMS/PLM systems (EDMS, PLM, Agile, Windchill, Arena).
• Ability to coordinate document reviews and audits.
• Strong documentation skills with high attention to detail.

Responsibilities

• Create, revise, route, and maintain engineering documents within the document control system.
• Manage document change requests including ECOs and ECNs.
• Ensure DHF, DMR, and technical documentation remain current and complete.
• Coordinate document approvals and ensure timely processing of revisions.
• Support engineers with formatting and organization of technical reports and specs.
• Organize product development records throughout the full design lifecycle.
• Ensure traceability between design requirements and verification activities.
• Assist with testing, validation records, and design reviews.
• Adhere to SOPs, FDA QSR, ISO requirements, and document control procedures.
• Support audits, regulatory inspections, and quality system reviews.

Skills

Document control

Attention to detail

Cross-functional collaboration

Regulatory familiarity

Communication skills

Tools

EDMS

PLM

Windchill

Arena

Microsoft Office

Job description

Actalent in Maple Grove, MN seeks a Documentation Specialist to manage day-to-day engineering documentation for investigational heart valve programs in an on-site role. You will create, maintain, review, and control documents, ensuring alignment with regulatory and quality requirements.

Work with Engineering, Quality, Regulatory, Manufacturing, and Clinical teams to assure DHF/DMR compliance, support audits, and drive process improvements using EDMS/PLM tools and Microsoft Office.