Senior Technical Writer, QMS – Product Security

Work Flexibility: Remote

Stryker is hiring a Senior Technical Writer, QMS – Product Security! In this role, you will be responsible for creating, reviewing, and maintaining high-quality documentation that complies with regulatory requirements and industry standards. You will translate complex technical information into clear, concise content, ensuring that all documentation aligns with QMS requirements.

What you will do:

• Role Focus: Technical Writer specializing in Quality Management Systems (QMS) for medical devices, responsible for creating and maintaining regulatory-compliant documentation that meets global standards.

• Core Documentation Duties: 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.

• Cross-Functional Collaboration: Work closely with product security, quality assurance, regulatory affairs, engineering, and manufacturing teams to gather technical information and coordinate document review/approval processes.

• Regulatory Compliance: 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

What you need:

Required:

• 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.

Preferred: 

• 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

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.