Document Controller (Part-Time)

Part-Time Document Control Specialist - Medical Device Industry
Location: New Hampshire Hybrid (as needed)
Position Type: Part-Time (20-25 hrs/week)
Industry: Medical Device / AI Surgical Navigation

Our fast-growing client in the medical device space is seeking a Part-Time Document Control Specialist to support its Quality Management System (QMS) . This role involves managing document control activities using an electronic Quality Management System (eQMS) to ensure efficient handling of controlled documents, records, and change management processes.

This opportunity is ideal for new grads/entry level professionals looking to kickstart their career in a fast-paced, dynamic environment, with opportunity to grow with the company. This position requires strong attention to detail and the ability to manage multiple priorities while ensuring compliance with industry standards.

Key Responsibilities:

Document Control Management:

• Maintain and update controlled documents within the eQMS.


• Manage document review, approval workflows, and version control.


• Oversee controlled distribution of policies, procedures, and work instructions.

Change Management Support:

• Assist with document change requests (DCRs) and engineering change orders (ECOs).


• Ensure document updates align with regulatory requirements.

Quality System Compliance:

• Support compliance with ISO 13485, FDA QSR (21 CFR Part 820), and EU MDR documentation requirements.


• Ensure records are properly maintained and accessible for audits and inspections.

Training & Communication:

• Coordinate document training assignments and track completion.


• Assist in internal audits by organizing and retrieving required documentation.

Qualifications:
Required:

• Basic experience in technical writing, document management


• Motivated and willing to learn new technology, processes, procedures


• Open to part time work, with opportunity to take on more work/hours in the future


• Strong attention to detail and ability to work efficiently in a high-growth environment.


• Proficiency in Microsoft Office (Word, Excel, Outlook).

Preferred:

• Experience in medical device startups or small teams.


• Background in internal and external audit support.


• Knowledge of risk management processes (ISO 14971) and design control documentation.


• Ability to adapt to evolving processes and regulatory requirements.


• Hands-on experience with eQMS software, preferably Orcanos.

Work Schedule & Compensation:

• Part-time (20-25 hours per week) with a flexible schedule.


• Remote work available, with occasional on-site meetings as needed.


• Competitive hourly rate based on experience.