• Senior Technical Writer, QMS - Product Security

    Stryker (Indianapolis, IN)


    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

     

    Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

     

    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.