Senior Technical Writer, QMS â Product Security
Senior Technical Writer, QMS â Product Security
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Salary Not Disclosed
1 Vacancy
Job Description
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 workflowsthrough regular reviews and ensure proper document lifecycle management
What you need:
Required:
Bachelors 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
Required Experience:
Senior IC
Employment Type
Full-Time
