Senior Technical Writer, QMS Product Security

About the Role

Key Responsibilities

• Develop quality manuals, playbooks, SOPs, work instructions, technical files, user manuals, Design History Files (DHF), and Device Master Records (DMR) while ensuring proper document control and lifecycle management.
• Work closely with product security, quality assurance, regulatory affairs, engineering, and manufacturing teams to gather technical information and coordinate document review/approval processes.
• Maintain current knowledge of medical device regulations, support regulatory submissions and audits, and ensure all documentation meets quality and compliance requirements across different markets.
• Support both internal and external audits.
• Improve process workflows through regular reviews and ensure proper document lifecycle management.

Requirements

• Bachelor's degree with 2+ years of related experience in a regulated industry, or a high school diploma with 8+ years of related experience in lieu of a degree.
• Demonstrated experience with QMS documentation, technical writing, and quality processes.
• Exceptional writing, editing, and proofreading skills combined with strong organizational abilities, meticulous attention to detail, and the capacity to manage multiple projects simultaneously with accuracy.

Nice to Have

• Knowledge of medical device regulations and standards (ISO 13485, FDA 21 CFR Part 820, EU MDR).
• Strong understanding of document control processes and systems.
• Proficiency with Microsoft Office suite and document management software.
• Ability to translate complex technical information into clear, user-friendly content.
• Knowledge of risk management principles (ISO 14971).
• Experience supporting regulatory submissions or audits.

Qualifications

• Educational background as specified in requirements (Bachelor's degree or equivalent experience).

Benefits & Perks

• Work Flexibility options including Remote, Field-based, Onsite, and Hybrid work arrangements.