RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
We're looking for a Technical Writer ideally from the Medical Device industry who can help create and maintain documentation for an ISO 13485 Quality Management System. In this role you will work with stakeholders to ensure that documentation is accurate, complaint and meets the needs of the users.
Primary Responsibilities
- Create documentation Write manuals, guides, and standard operating procedures (SOPs) that explain technical processes
- Updates documentation: Keep documentation up to date to reflect changes in processes and procedures
- Prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends
- Work with subject matter experts, management, and employees to ensure documentation is accurate and meets needs
- Ensure compliance. Make sure documentation meets industry standards, legal requirements, and guidelines
- Improve processes. Work with the QA department to improve quality across deliverables
Requirements
- Bachelor’s degree in a related field
- Technical or engineering degree preferred
- 3- 7 years of experience
- Medical Device experience preferred
- Knowledge of ISO 13485 preferred
- Strong writing skills
- Ability to communicate quickly and clearly (written and verbal)
- Attention to detail
- Ability to write quality plans and procedures
- Ability to balance quality compliance with business needs
- Ability to work cross-functionally in a matrix organization
- Strong understanding of quality system management
Behaviours
- Action-Oriented, Analytical Mindset, Approachability, Business Acumen, Career Ambition, Composure, Courage, Customer Focus, Decision Quality, Detailed Oriented, Communication, Integrity & Trust, Interpersonal Savvy, Planning, Prioritizing, Time Management
Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!
We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
Job Opportunity Verification
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Top Skills
What We Do
RQM+ is the world’s leading provider of regulatory, clinical and quality solutions to the MedTech industry. We deliver transformative solutions to customers by providing unrivaled collective knowledge and expertise, fueled by our passion for customer success. Our experts are collaborative, laser-focused on customer needs, and committed to delivering high-value solutions for both medical devices and diagnostics that exceed expectations.
Learn more about our services, free resources, and more at www.RQMplus.com
