Technical FDA Writer
About The Position
Millstone Medical is a fast-growing, fast-paced medical service provider for top Orthopedic companies. Millstone specializes in sterile and non-sterile packaging of medical devices, as well as mechanical inspection and assembly, to meet the outsourcing needs of medical device manufacturers. The company is FDA and ISO registered and maintains a robust internal quality system. This role is crucial for authoring, revising, and maintaining the controlled documentation that supports Millstone's Quality Management System (QMS), ensuring compliance with FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016. The Technical FDA Writer collaborates with various departments to translate regulatory requirements and operational processes into clear, defensible documentation.
Requirements
- Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Technical Communication, English, or a related field.
- 3–7 years of technical writing experience in a medical device, pharmaceutical, or FDA-regulated manufacturing environment.
- Demonstrated experience authoring SOPs, Work Instructions, and controlled procedures within a QMS.
- Direct experience with 21 CFR Part 820 (QMSR) and ISO 13485:2016 documentation requirements.
- Experience supporting audits (FDA, ISO certification body, or customer audits).
- Working knowledge of QMSR / 21 CFR Part 820, ISO 13485:2016, and 21 CFR Part 11 (electronic records).
- Proficient with electronic document management systems (e.g., MasterControl, Veeva QualityDocs, Greenlight Guru, ETQ, or equivalent).
- Advanced proficiency with Microsoft Word (styles, cross-references, templates).
- Proficiency with Visio or Lucidchart for process flow diagrams.
- Proficiency with PDF finalization workflows.
- Proficiency with Microsoft 365 (Teams, SharePoint, OneDrive) for collaborative document development and controlled distribution.
- Familiarity with change control workflow tools and impact assessment methodologies.
Nice To Haves
- Advanced degree (e.g., MS in Regulatory Affairs, Technical Communication, or related).
- Experience with medical device 3PL, contract manufacturing, or supply chain operations.
- RAC (Regulatory Affairs Certification) from RAPS.
- ASQ CQA (Certified Quality Auditor) or CQE (Certified Quality Engineer).
- Technical writing certifications (STC, or vendor-specific such as MadCap).
- Lean Six Sigma Green Belt or equivalent.
Responsibilities
- Authoring and revising Standard Operating Procedures (SOPs), Work Instructions (WIs), Playbooks (PBs), forms, and other QMS documentation.
- Managing the full document lifecycle, from draft to obsolescence, adhering to document control procedures.
- Coordinating change control processes for QMS documents, including impact assessments and planning.
- Monitoring updates to FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016, and translating these into QMS document updates.
- Supporting gap analyses of the QMS against regulatory requirements and customer agreements.
- Identifying and proposing improvements to document structure, readability, and usability.
- Developing or supporting the development of training materials linked to controlled procedures.
- Supporting the drafting and revision of Quality Agreements between Millstone Medical and customer manufacturers.
- Collaborating with Operations, Quality, and customer program owners to ensure documentation reflects operational reality and regulatory requirements.
- Authoring customer-specific procedures, work instructions, and reference documents for new programs.
Benefits
- Medical
- Dental
- Vision
- Supplemental Benefits - Life, Disability, Critical Illness
- Paid Time Off
- Tuition Reimbursement
- Career Pathing
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
