Quality Assurance Associate

Clarion Medical Technologies Inc.; Cambridge; On-site; CAD 65,000 - 90,000; Full time

Benefits offered by this job

Extended healthcare benefits

Pension plan with employer match

Paid vacation time and personal days

Mentorship and career planning

Education and training programs

Job summary

Clarion Medical Technologies is seeking a Quality Assurance Associate to ensure products meet GMP requirements and Health Canada regulations. You will help maintain the QMS/eQMS, manage CAPAs, and support regulatory submissions for cosmetics, NPNs, and DINs.

The role emphasizes meticulous documentation, root-cause investigations, supplier qualification, and continuous improvement across the organization. Join a team committed to high-quality medical devices and patient outcomes.

Qualifications

• Bachelor's degree in Science or a related field.
• 3–5 years of Quality Assurance experience in a regulated industry.
• Strong knowledge of GMP, Health Canada regulations, CAPA processes, complaint handling, and batch release activities.
• Experience with Quality Management Systems (QMS/eQMS), supplier qualification, and regulatory submissions is an asset.
• Strong analytical, investigative, and problem-solving skills with exceptional attention to detail.
• Proficient with computer systems and documentation management.
• Excellent organizational, communication, and interpersonal skills with the ability to manage multiple priorities.

Responsibilities

• Facilitate batch releases and ensure compliance with Health Canada regulations and GMP requirements.
• Support the maintenance and continuous improvement of the Quality Management System (QMS) and electronic QMS (eQMS).
• Manage customer complaints, product investigations, CAPAs, and quarantined inventory, including root cause analysis and resolution.
• Maintain GMP compliance activities, including supplier reviews, post-market surveillance (PMS), testing programs, and quality documentation.
• Support DEL renewals, traceability activities, vendor qualification, temperature monitoring, receiving inspections, and batch record reviews.
• Prepare and submit product registrations, including Cosmetics, NPNs, and DINs.
• Ensure accurate, complete, and audit-ready quality records while promoting a culture of quality and compliance across the organization.

Skills

Quality Assurance

GMP knowledge

Health Canada regulations

CAPA processes

Investigative skills

Attention to detail

Analytical skills

Communication skills

Organizational skills

Education

Bachelor's degree in Science or related field

Tools

QMS/eQMS

Regulatory submissions

CAPA management software

Job description

Clarion Medical Technologies, a part of Richards Group, specializes in surgical, vision and aesthetic healthcare medical devices. Some of these products include laser technologies, diagnostic tools for early disease detection and advanced imaging systems. At Clarion, we are dedicated to empowering healthcare providers with the tools and expertise to deliver outstanding patient outcomes, while shaping the future of medical technology and aesthetics in Canada.

Why join Clarion:

• Generous compensation package including a competitive base salary and variable compensation
• Fantastic extended healthcare benefits for you and your family
• Extended personal spending account to be used on health and wellness such as gym memberships
• Pension plan with employer match contributions
• Paid vacation time and personal days
• Monday-Friday day shift operations with work/life balance at the forefront
• Mentorship, professional development, and commitment to career planning
• Paid education and training programs
• Lunch & learns, volunteer time and a focus on supporting our community
• Collaborative, open concept office
• And so much more!

About the Role:

Reporting to the VP of Regulatory Affairs and Quality Compliance, the Quality Assurance Associate will be responsible for ensuring our products consistently meet quality standards, Good Manufacturing Practice (GMP) requirements, and Health Canada regulations. You will play a key role in maintaining and improving our Quality Management System (QMS), supporting product registrations, managing quality investigations, and driving continuous improvement initiatives across the organization.

This position is for an open vacancy.

The successful applicant will:

• Facilitate batch releases and ensure compliance with Health Canada regulations and GMP requirements.
• Support the maintenance and continuous improvement of the Quality Management System (QMS) and electronic QMS (eQMS).
• Manage customer complaints, product investigations, CAPAs, and quarantined inventory, including root cause analysis and resolution.
• Maintain GMP compliance activities, including supplier reviews, post-market surveillance (PMS), testing programs, and quality documentation.
• Support DEL renewals, traceability activities, vendor qualification, temperature monitoring, receiving inspections, and batch record reviews.
• Prepare and submit product registrations, including Cosmetics, NPNs, and DINs.
• Ensure accurate, complete, and audit-ready quality records while promoting a culture of quality and compliance across the organization.

We are seeking a candidate with the following experience and attributes:

• Bachelor's degree in Science or a related field.
• 3–5 years of Quality Assurance experience in a regulated industry (pharmaceutical, natural health products, cosmetics, or related).
• Strong knowledge of GMP, Health Canada regulations, CAPA processes, complaint handling, and batch release activities.
• Experience with Quality Management Systems (QMS/eQMS), supplier qualification, and regulatory submissions is an asset.
• Strong analytical, investigative, and problem-solving skills with exceptional attention to detail.
• Proficient with computer systems and documentation management.
• Excellent organizational, communication, and interpersonal skills with the ability to manage multiple priorities.

Clarion Medical Technologies is an equal-opportunity employer and is committed to creating an inclusive employee experience for all. We firmly believe that our work is at its best when everyone feels free to be their most authentic self. If you require accommodation, please let us know how we can further support you during the recruitment process.