Technical Writer

As a Technical Writer at RQM+, your primary responsibilities include creating and maintaining documentation for the ISO 13485 Quality Management System. This involves writing manuals, guides, and standard operating procedures (SOPs) that accurately explain technical processes. You'll also ensure that documentation is continuously updated, collects and analyzes information for quality reports, and collaborates with subject matter experts to maintain accuracy and compliance with industry standards.

To qualify for the Technical Writer position at RQM+, candidates should have a Bachelor’s degree in a related field, with a strong preference for technical or engineering degrees. You’ll need 3-7 years of experience, ideally in the Medical Device industry, along with knowledge of ISO 13485 and strong writing skills. Effective communication, attention to detail, and the ability to work cross-functionally in a matrix organization are also crucial.

RQM+ is committed to the continuous learning and development of its employees, including Technical Writers. The company invests heavily in providing ongoing training and opportunities for professional growth, ensuring that you can advance your career while working in a supportive and engaging environment that values your contributions.

As a Technical Writer at RQM+, you'll enjoy the flexibility of a remote work environment in the United States, which promotes work-life balance. The culture at RQM+ is highly collaborative and supportive, making it possible for you to engage with colleagues across departments while contributing to essential quality and regulatory processes in the MedTech industry.

Essential skills for a Technical Writer at RQM+ include strong writing and communication skills, ability to pay attention to detail, and the capacity to balance quality compliance with business needs. Familiarity with ISO 13485 standards and the ability to compose quality plans and procedures are also vital. Furthermore, having an analytical mindset and being action-oriented will help you thrive in this technical role.

When answering this question, detail any specific projects or documentation you've worked on related to ISO 13485. Explain how you ensured compliance and what processes you followed to keep the documentation accurate and up-to-date. Emphasize your familiarity with regulatory requirements and provide examples that highlight your attention to detail.

In your response, discuss your strategies for engaging effectively with subject matter experts. Highlight your communication skills and how you initiate discussions to gather information. You can mention any specific tools or methods you utilize to ensure information is communicated clearly and accurately.

Use this question to illustrate a specific scenario where you updated documentation. Discuss the steps you took to gather new information, how you verified its accuracy, and any feedback loops you established with team members to ensure the final product was error-free and clear.

Detail your time management strategies when discussing this question. You might want to describe tools you use to prioritize tasks, how you set timelines for documentation projects, and methods for communicating with colleagues to manage expectations effectively.

Provide a specific example where adherence to industry standards was critical. Discuss how you approached your work with compliance in mind and any checks or reviews you implemented to meet regulatory guidelines.

Discuss your approachability and openness to feedback. Explain how you welcome critiques as a part of the learning process and provide examples of how you’ve successfully incorporated feedback into your work to improve the final documentation.

List the software tools you are comfortable using, such as Microsoft Word, Adobe Acrobat, or specialized documentation tools. Explain how you've utilized these tools to create and manage documentation efficiently, potentially providing examples of projects where they were instrumental.

Mention techniques you apply to make technical content accessible to various audiences. Discuss the importance of structure, clear language, and visual aids in enhancing understanding and how you tailor documentation based on user needs.

Explain your commitment to professional development through continuous learning methods. Include resources such as industry publications, webinars, or relevant conferences that you engage with to remain knowledgeable about regulations and best practices.

Articulate your passion for the MedTech field and RQM+'s role as an industry leader. Discuss how your values align with theirs, your enthusiasm for contributing to impactful documentation, and your eagerness to be part of a collaborative team that prioritizes quality and compliance.