Technical FDA Writer

Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!

Millstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone’s business focus is sterile and non-sterile packaging of medical devices.

Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.

A company committed to quality, growth, career pathing.

At Millstone, we want you to be your best at work and  addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.

• Medical, Dental & Vision
  - Starting on the 1st day of employment
• Supplemental Benefits
  - Life, Disability, Critical Illness
• Paid Time Off
• Tuition Reimbursement
• Career Pathing

The Technical FDA Writer is responsible for authoring, revising, and maintaining the controlled documentation that underpins MMO's Quality Management System (QMS). This role owns the drafting and revision of Standard Operating Procedures (SOPs), Work Instructions (WIs), Playbooks (PBs), forms, and supporting quality documentation used across MMO's operational sites in support of FDA 21 CFR Part 820 (QMSR) and ISO 13485:2016 compliance.

This role works cross-functionally with Quality, Operations, IT, and customer program owners to translate regulatory requirements and operational realities into clear, defensible, audit-ready documentation.

The Technical FDA Writer is a mid-level individual contributor role and a critical link between MMO's operational teams and its regulatory posture. The right person is a strong writer with medical device regulatory grounding, comfortable with complex operational subject matter, and rigorous about document control discipline.

• SOP authoring and revision
  - Draft new SOPs and revise existing SOPs (including but not limited to the SOP-OB-INTL series and all department-level SOPs) in alignment with QMSR / ISO 13485 requirements and MMO's document control conventions.
• Work Instruction development
  - Author WIs (including the WI-OB-INTL series and equivalents) that translate SOP-level requirements into operator-executable steps with appropriate visual aids, checklists, and decision criteria.
• Playbook authoring
  - Develop Playbooks (PB-OB-INTL and equivalents) that provide role-based operational guidance combining process, tools, escalation paths, and success criteria.
• Forms and templates
  - Create and maintain controlled forms, templates, and record structures that support consistent execution and audit-defensible recordkeeping.
• MMO Quality Manual maintenance
  - Support the Quality Manager in maintaining the MMO Quality Manual and top-level QMS documentation, including revisions triggered by regulatory updates, organizational changes, or continuous improvement initiatives.

• Document lifecycle management
  - Manage documents through the full lifecycle: draft, review, approval, effective date, revision, and obsolescence, in accordance with MMO's document control procedure.
• Change control coordination
  - Prepare change control packages for QMS document changes, including impact assessments, training requirements, and effective date planning.
• Reference document integration
  - Support the implementation of the Authorized Reference Model where customer-owned procedures are referenced within MMO's QMS; author the master procedure and per-program authorization documents that establish this framework.

• Regulatory currency
  - Monitor updates to FDA 21 CFR Part 820 (QMSR), ISO 13485:2016, and applicable guidance documents; translate changes into required QMS…