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.
This position is responsible for ensuring that our products and services consistently meet the highest quality standards. This role involves developing, implementing, and maintaining quality assurance and/or quality control processes, while overseeing compliance with both internal, external standards and client expectations. The position will support continuous improvement initiatives and the effective implementation and maintenance of quality assurance systems and corporate / facility programs. Additionally, this individual ensures that organizational processes and products align with established quality criteria, contributing to the overall success and efficiency of the company’s quality management efforts.
Primary Responsibilities:
- Assist with the ongoing maintenance and improvement of the Quality Management System (QMS), ensuring its effectiveness and alignment with company goals and regulatory requirements.
- Oversee and monitor compliance with both internal quality standards and external regulations or certifications (e.g., ISO, GMP, GLP, FDA).
- Ensure all processes, products, and services align with the organization’s quality objectives and industry standards.
- Manage and maintain quality-related documentation, including inspection reports, testing records, and quality audits.
- Ensure proper documentation control, ensuring all records are accurate, up-to-date, and compliant with regulatory requirements.
- Assist in conducting internal audits and inspections to evaluate adherence to quality processes and standards.
- Assist in reviewing, analyzing, evaluate, and document results associated with client supporting processes.
- Coordinate audit schedules, prepare audit reports, and track corrective actions following audit findings.
- Collect and analyze quality data, such as test results, performance metrics, and customer feedback.
- Support continuous improvement initiatives by recommending and helping to implement changes to improve efficiency, reduce errors, and enhance product quality.
- Provide training and guidance to employees on quality assurance procedures, regulatory compliance, and best practices.
- Foster awareness of quality standards across the organization, encouraging adherence to quality practices at all levels.
- Track and follow up on corrective and preventive actions (CAPAs) to ensure the resolution of identified issues.
Requirements:
- 2+ years of experience in quality assurance or quality control role, preferably in [industry, e.g., manufacturing, healthcare, software, etc.].
- Familiarity with quality management systems (QMS) and regulatory requirements (ISO 9001, GMP, etc.).
- Quality Certification(s) preferred
- Strong attention to detail and analytical skills.
- Excellent written and verbal communication skills.
- Proficiency in MS Office Suite (Excel, Word, PowerPoint), with the ability to learn new software tools.
- Ability to work independently and as part of a team.
- Problem-solving skills, with the ability to analyze issues and propose practical solutions.
- Quality Certifications (preferred, but not required)
Behaviours:
- Customer Focus, Strong Written and Verbal Skills, Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning, Multi-Tasking, Flexible / Adaptable and Analytical
Supervisory Responsibilities
- This position does not have supervisory responsibilities.
Work Environment/Physical Demands
- This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.
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/careersEvery 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.Apply for this job
