RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.
We don’t make MedTech. We make MedTech happen.
Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.
Job Summary:
The Quality Systems Implementation Specialist will support the implementation and alignment of global Quality Management System (QMS) processes across multiple business entities and sites. This role partners closely with Quality teams, Global Process Owners, and cross-functional stakeholders to understand current-state quality systems, support process implementation activities, and ensure alignment of local procedures with global standards.
The ideal candidate has experience working within a regulated environment, understands quality system requirements, and has strong project coordination skills to support global initiatives, documentation updates, and continuous improvement efforts.
Primary Responsibilities:
QMS Assessment & Alignment
- Partner with Quality representatives across multiple business entities to understand, assess, and document site-specific Quality Management Systems (QMS)
- Support evaluation of existing processes, procedures, and documentation to identify alignment opportunities and potential gaps
- Assist with maintaining consistency between local quality practices and global quality standards
Global Process Implementation
- Collaborate with Global Process Owners to understand implementation requirements, timelines, milestones, and deliverables for new or updated quality processes
- Support deployment of global processes across local sites and business units
- Assist with alignment and updates to local procedures, SOPs, and work instructions to ensure consistency with global requirements
Project Coordination & Execution
- Coordinate cross-functional activities to support successful implementation of quality initiatives
- Track project activities, deliverables, timelines, and dependencies to ensure progress
- Support identification of risks, issues, and barriers and escalate as appropriate
Meeting Coordination & Communication
- Coordinate project meetings with global and local stakeholders
- Document meeting minutes, decisions, action items, and key outcomes
- Drive accountability by tracking action items and following up with stakeholders to ensure timely completion
Documentation & Compliance Support
- Assist with reviewing, redlining, updating, and aligning quality system documentation, including SOPs, procedures, and work instructions
- Support document review, approval, and implementation workflows within electronic Quality Management Systems (eQMS)
- Ensure documentation updates support regulatory compliance and quality system requirements
Education/Work Experience:
- Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field
- 3–7 years of experience in:
- Quality Systems, Regulatory Affairs, Process Improvement, or related functions within a regulated industry
- Project or program coordination/management
- Working knowledge of Quality Management Systems within a regulated environment, including ISO 13485 and FDA 21 CFR Part 820
- Experience supporting process improvements, system implementations, or quality initiatives across multiple sites or business units
- Strong organizational skills with the ability to manage multiple priorities and timelines
- Excellent written and verbal communication skills
Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
Requirements:
- Experience in the medical device, pharmaceutical, biotechnology, or life sciences industry
- Experience supporting global QMS harmonization, integration, or transformation initiatives
- Familiarity with electronic Quality Management Systems (eQMS) such as Oracle Agile, Veeva, or TrackWise
- Knowledge of change management principles and implementation methodologies
- Experience working with global, cross-functional teams
- Collaborates within a global, cross-functional team environment supporting teams across Europe, Australia, and other regions
- Requires coordination across multiple time zones
- Remote position with limited travel requirements
Supervisory Responsibilities: There will be no supervisory responsibilities.
Work Environment & Physical Requirements This is a remote position. The employee is expected to maintain a dedicated, distraction-free home workspace with reliable high-speed internet access. Core working hours are determined by role responsibilities, client expectations, and business needs.
Travel This role may require travel as business needs dictate, including overnight trips for client meetings, team collaboration, training sessions, and company events
Physical Demands The role involves prolonged periods of sitting and computer use, including frequent typing, video conferencing, and extended screen time. During travel or on-site activities, the employee may be required to stand or walk for extended periods, navigate office and client environments, and lift or carry materials or luggage up to 25 pounds.
Workspace & Accommodations The employee is responsible for maintaining a safe, ergonomic home workspace. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions of this role.
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
At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:
All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
Every candidate going through the interview process will participate in a voice and/or video interview.
Exercise caution with unsolicited job offers or requests for sensitive information.
