Job Summary:
Red Rock Regeneration is seeking a hands-on Quality Manager to build, implement, and maintain the company's Quality Management System across tissue-based products and our emerging medical device programs.
This role is ideal for an experienced quality professional who thrives in an entrepreneurial environment and is comfortable balancing strategic quality planning with day-to-day execution. The successful candidate will play a key role in establishing scalable quality processes that support product development, manufacturing, regulatory compliance, and future company growth.
The Quality Manager will partner closely with Regulatory, Product Development, Clinical Evidence, Sales and Marketing and our external manufacturing and distribution partners to ensure quality systems remain compliant, practical, and fit for purpose. While experience with tissue products, biologics, regenerative medicine, or combination products is considered an asset, the primary focus of this role is the development and maintenance of a robust medical device quality system, including design controls, risk management, supplier quality, document control, CAPA, and audit readiness.
JOB DESCRIPTION
Reports to: VP of Regulatory, and works closely with QMS consultant.
Location: Toronto (65 International Blvd.)
Terms: Hybrid (in office at least 3 days per week)
Hours: 40 hours per week, Monday to Friday (permanent full-time)
Salary: $100,000 – 135,000 (CAD) annual pay (based on experience).
Duties & Responsibilities:
Quality Management System
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485.
- Establish and maintain quality documentation, including quality policies, SOPs, and records.
- Support internal and external audits and ensure ongoing audit readiness.
Product Development Quality
- Support design controls, risk management, change control, and document control activities.
- Partner with Regulatory, Product Development, and Manufacturing to integrate quality throughout product development.
Supplier & Manufacturing Quality
- Support supplier qualification and oversight of external manufacturing partners.
- Contribute to manufacturing quality activities, investigations, CAPA, and process improvements.
Quality Operations & Compliance
- Manage quality processes including CAPA, nonconformances, training, and eQMS administration.
- Monitor quality metrics and drive continuous improvement initiatives.
- Support quality compliance activities and organizational growth.
Critical Competencies Required
Knowledge:
- Strong working knowledge of ISO 13485 and medical device quality systems.
Skills & Experience:
- Minimum 5 years of progressive quality experience within the medical device industry.
- Experience developing, implementing, and maintaining quality system processes and documentation, including quality policies, quality objectives, SOPs, forms, templates, and quality records.
- Experience with design controls, risk management, change control, CAPA, document control, and training processes.
- Experience leading internal and external audits.
- Hands-on experience with electronic Quality Management Systems (eQMS).
- Experience working cross-functionally with product development, manufacturing, regulatory, and operations teams.
- Strong organizational, communication, and problem-solving skills.
- Ability to work independently and effectively in a startup or growth-stage environment.
QUALIFICATIONS
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Biotechnology or a related discipline.
Preferred Qualifications/Experience
- Experience with orthopedic, implantable, bone repair, tissue-based, regenerative medicine, or combination products.
- Experience supporting supplier quality, manufacturing quality, process validation, and technology transfer activities.
- Exposure to GMP-regulated environments, biologics, recombinant proteins, batch records, or master records.
- Experience working with contract manufacturers, tissue establishments, or external development partners.
Accommodations for applicants with disabilities are available upon request
Pay: $100,000.00-$135,000.00 per year
Work Location: Hybrid remote in Etobicoke, ON M9W 6L9
