Technical Writing Team Lead - QMS Standardization

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients - faster, safer, better.

We don't make MedTech. We make MedTech happen.

Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.

Job Summary:

The Technical Writing Team Lead is a player-coach role within our Client''s QMS Standardization program, responsible for both leading a team of technical writers and personally completing technical writing tasks. This individual will ensure that all standardized global QMS documents are consistent, compliant, user-friendly, and produced as if written by a single team - supporting our Client''s vision to "Design Anywhere, Build Anywhere, Transfer Anywhere."

The program spans 22 Key Processes (31 networks/subprocesses) across six global entities.

Primary Responsibilities:

Team Leadership

• Lead, mentor, and coordinate a team of technical writers supporting the QMS Standardization program
• Assign work across the team based on Key Process priorities and Change Order timelines
• Serve as the primary point of contact between the technical writing team and program leadership.
• Monitor team workload, capacity, and quality of output; escalate issues to program leadership as needed
• Support onboarding of new technical writers
• Review technical writers' outputs for consistency
• Maintain and update the Technical Writing SharePoint site, folder structures, and document trackers
• Coordinate with Change Analysts to ensure smooth routing of documents through the change control process
• Contribute to continuous improvement of technical writing workflows, style guides, and templates

Hands-On Technical Writing

• Transform draft content from Global Process Owners (GPOs) and Global Process Stewards (GPSs) into polished, consistent global QMS documents
• Ensure all documents comply with the Standardization Style Guide, Policy Content Guidance, and SOP-WI Content Guidance
• Enforce correct template usage across the full document hierarchy
• Correct spelling, grammar, and formatting using tracked changes in Microsoft Word
• Use Client''s GPT and other tools to improve conciseness and compliance of document language
• Collaborate with GPOs and GPS networks to align on edits, resolve comments, and incorporate stakeholder feedback
• Kick off the Change Order (CO) process; create markup (redline) and clean copies of final documents
• Create the Bill of Documents (BOD) in PLM for applicable documents
• Update document trackers and communicate status to program leadership

Process & Governance

• Manage and triage incoming work through the Technical Writing Request Form (SharePoint)
• Ensure all submissions include required attachments: draft documents, notes, target completion dates, and TW Document Trackers
• Maintain document status across the Technical Writing SharePoint site folder structure (In Progress, Under Review, Complete)

Education/Work Experience/Requirements:

• Bachelor''s degree in English, Communications, Technical Writing, Life Sciences, Quality, or a related field
• 5+ years of technical writing experience, preferably in a regulated medical device, pharmaceutical, or life sciences environment
• Experience with Quality Management Systems (QMS) documentation including SOPs, Work Instructions, Policies, and Forms
• Strong knowledge of document control processes and change control workflows
• Proficiency with Microsoft Word (tracked changes, styles, formatting), SharePoint, and PLM systems (Agile Oracle PLM preferred)
• Demonstrated ability to lead or mentor a team of writers
• Excellent attention to detail, grammar, and writing consistency
• Strong interpersonal and communication skills - ability to work collaboratively with subject matter experts, GPOs, and GPS networks across global entities
• Ability to manage multiple concurrent projects and deadlines in a fast-paced program environment
• Experience with ISO 13485, FDA 21 CFR Part 820, or MDR QMS requirements
• Experience using AI writing tools (e.g., ChatGPT) for document improvement
• Player-coach mindset: leads by example and contributes directly to deliverables
• Disciplined attention to detail and consistency
• Collaborative, service-oriented approach to working with content owners
• Strong organizational and project coordination skills
• Proactive communicator - does not hesitate to reach out to leadership or authors

Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning

Supervisory Responsibilities:

Work Environment & Physical Requirements:

This is a remote position. The employee is expected to maintain a dedicated, distraction-free home workspace with reliable high-speed internet access. Core working hours are determined by role responsibilities, client expectations, and business needs.

These requirements reflect what''s typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know - we''re happy to discuss options.

Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!

We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.

Job Opportunity Verification:

At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:

• All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
• Every candidate going through the interview process will participate in a voice and/or video interview.
• Exercise caution with unsolicited job offers or requests for sensitive information.