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 role is responsible for developing, managing, and continuously evaluating policies, processes, and procedures to ensure the organization delivers compliant client services in alignment with ISO 9001 and any specific business unit standards.
The Quality Engineer will lead, coach, and teach RQM+ employees, promoting an understanding of quality system philosophies, methodologies, and expectations. This guidance helps maintain internal compliance and ensures that quality standards are consistently met.
The role also drives continuous improvement within the quality management framework, identifying process enhancements and ensuring adherence to best practices, while fostering a culture of quality that meets client needs and regulatory requirements.
Primary Responsibilities:
- Support the management of the Quality Management System (QMS) to ensure compliance with applicable standards, regulations, and company expectations.
- Develop, implement, administrate and maintain quality assurance processes and procedures, ensuring they align with the company’s QMS, regulatory requirements, and industry standards.
- Lead and support internal and external audits, ensuring that the company is adequately prepared for regulatory inspections and certifications.
- Conduct risk assessments for new and existing processes, services or products; collaborating with cross-functional teams to implement effective risk management strategies.
- Lead and support various verification and validation activities, ensuring that manufacturing and service processes meet all regulatory and quality standards.
- Manage corrective and preventive action processes, investigating product defects, non-conformances, and customer complaints, and ensuring that corrective actions are effectively implemented.
- Perform root cause analysis and collaborate with teams to implement corrective and preventive actions to enhance product quality and process efficiency.
- Evaluate, qualify, and monitor suppliers, ensuring their products and processes meet both company and regulatory standards, and manage supplier quality issues as needed.
- Provide regular reports on quality metrics and key performance indicators (KPIs) to senior management, tracking trends, compliance, and the effectiveness of quality initiatives.
- Drive continuous improvement of the QMS, identifying, defining, and implementing process enhancements and tools to optimize quality performance and efficiency.
- Providing leadership, mentoring, and/or coaching others in best practices of quality principles and methodologies; including those adopted by the organizational quality system.
Requirements:
- Bachelor’s degree in quality assurance, technical or related field.
- Minimum 3-5 years of quality system experience in a regulated industry, medical device (preferred) or ISO 9001 environment.
- Experience leading multiple projects in a fast-paced environment
- Process Improvement experience preferred (Six Sigma, Lean or similar)
- Certifications (preferred, but not required): Certified Quality Engineer (CQE) or other relevant quality certifications.
- Strong analytical and problem-solving skills, with the ability to perform root cause analysis and drive continuous improvement.
- Excellent communication skills, both written and verbal, with the ability to present complex quality issues clearly to cross-functional teams and management.
- Proficient in the use of quality management software and tools
- Strong attention to detail and a proactive approach to identifying and resolving quality issues.
- Ability to coach, teach and lead others; work cross-functionally in a matrix organization
- Ability to manage multiple projects and highly adaptable to business needs
- Strong understanding of quality system management
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 may not have supervisory responsibilities.
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.
