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Documentation Specialist - Medical Devices
Job
Millibar Robotics
Hudson, MA (In Person)
$67,600 Salary, Part-Time
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Job Description
About the Role Millibar Robotics is seeking a part-time Documentation Specialist to support our growing medical device and precision manufacturing operations. This role reports directly to the President and is ideal for someone experienced in regulated environments who can help ensure our documentation systems meet industry and audit standards. Key Responsibilities
- Create, maintain, and organize quality and manufacturing documentation
- Support and improve documentation for ISO 13485 and
FDA 21 CFR
Part 820 compliance- Assist with document control processes, including revisions, approvals, and archiving
- Prepare and organize materials for internal and external audits
- Ensure consistency, accuracy, and traceability across all documentation
- Work directly with engineering and operations teams to capture process details Qualifications
- Experience in medical device or regulated manufacturing environments
- Strong working knowledge of ISO 13485 and
FDA 21 CFR
Part 820- Demonstrated success supporting or participating in passed audits
- High attention to detail and organizational skills
- Ability to work independently and communicate clearly across teams Position Details
- Part-time, flexible hours (schedule can be tailored)
- On-site required in Hudson, MA
- Reports directly to the President
- Opportunity to contribute to a fast-growing, hands-on engineering team Preferred (Not Required)
- Experience with quality management systems (QMS)
- Familiarity with CNC/manufacturing documentation or shop travelers
- Experience in small company environments Why Millibar Robotics
- Work directly with leadership and engineering
- Make a visible impact on systems and compliance
- Flexible schedule with meaningful, hands-on work
Pay:
$30.00- $35.