Quality and Compliance Specialist

Canada Masq Corporation; Richmond Hill; On-site; CAD 80,000 - 90,000; Full time

Job summary

A leading manufacturer of disposable medical supplies is seeking a Quality and Compliance Specialist to enhance their Quality Management System. This role involves ensuring compliance with regulatory standards, leading audits, and driving continuous improvement initiatives. The ideal candidate will have a strong background in quality assurance within the medical device industry and a passion for innovation.

Qualifications

• Minimum 1 year of experience in quality assurance or regulatory compliance.
• Familiarity with sterilization validation and ISO 10993 material biocompatibility testing.

Responsibilities

• Ensure ongoing compliance with Health Canada and FDA regulations.
• Lead internal and external QMS audits.
• Oversee and maintain the company’s Post-Market Surveillance program.

Skills

Analytical

Detail-Oriented

Communication

Project Management

Collaboration

Education

Bachelor’s degree in life sciences

Bachelor’s degree in engineering

Bachelor’s degree in regulatory affairs

Tools

ISO 13485

MDSAP

FDA QSR

CAPA

QMS

Job description

Job Description: Quality and Compliance Specialist

Department: Operations

Wage Category: $80,000-$90,000

Annually Reports to: VP of Operations/CEO

Revision Date: May 2025

Job Summary: The Quality and Compliance Specialist plays a critical leadership role in maintaining and advancing Canada Masq’s Quality Management System in alignment with ISO 13485, MDSAP, Health Canada, and FDA requirements. This role oversees quality assurance operations, internal audits, regulatory submissions, CAPAs, product recalls, and supplier quality. As the company expands into Class II medical devices, the manager will also drive compliance in New Product Development and post-market surveillance activities.

Canada Masq is an evolving and fast-moving organization where priorities shift quickly, and team members are expected to wear multiple hats, think creatively, and step outside of their comfort zones. We’re looking for someone who brings strong regulatory experience and a passion for continuous improvement, along with the initiative to build solutions and drive innovation as we pursue our mission to become a leading manufacturer of disposable medical supplies in North America.

Key Responsibilities

• Ensure ongoing compliance with Health Canada (MDEL/MDL), and FDA (21 CFR 820) regulations.

• Lead internal and external QMS audits

• Design, implement, and continuously improve a robust Quality Management System (QMS) that meets ISO 13485, MDSAP, and applicable regulatory requirements. Lead the transition from a basic SharePoint-based system to a dedicated electronic QMS platform, serving as the system builder, owner, and internal champion.

• Oversee and maintain the company’s Post-Market Surveillance program, including complaint handling, vigilance reporting, trending analysis, and managing the full lifecycle of CAPAs and product recalls, with timely and compliant communication to regulatory authorities and customers.

• Conduct Management Reviews, track QMS performance metrics, and collaborate crossfunctionally to drive continuous improvement and a culture of operational excellence.

• Coordinate and ensure compliance with sterilization validation and biocompatibility testing (ISO 10993), as required for Class II product development.

• Support regulatory submissions and maintain product registrations and licenses, including preparation of FDA 510(k) submissions and MDL Application for Class II medical devices.

• Provide quality assurance leadership in New Product Development, including design controls, risk management, validation, and technical documentation.

• Lead critical supplier quality management, including onboarding, risk assessments, audits, and performance monitoring.

• Monitor regulatory developments in Canada and the U.S., and serve as the primary liaison with regulatory consultants, external auditors, and certifying bodies to ensure proactive compliance and inspection readiness.

Qualifications:

• Bachelor’s degree in life sciences, engineering, or regulatory affairs.

• Minimum 1 year of experience in quality assurance or regulatory compliance within the medical device or life sciences industry.

• Demonstrated knowledge of ISO 13485/2016, MDSAP, Health Canada regulations, SOR/98-282 (Canadian Medical Device Regulations), and FDA QSR (21 CFR 820) regulations.

• Proven Success with FDA 510(k) submissions (U.S.), and MDAL Applications (Canada).

• Hands-on experience managing electronic QMS platforms and leading CAPAs, product recalls, audits, and supplier quality programs, with direct involvement in design controls, risk management, and validation during New Product Development.

• Familiarity with sterilization validation and ISO 10993 material biocompatibility testing

• Certifications such as RAC (Regulatory Affairs Certification – offered by RAPS) and ASQ (American Society for Quality certifications such as CQA – Certified Quality Auditor, CQE – Certified Quality Engineer, or CMQ/OE – Certified Manager of Quality/Organizational Excellence) is preferred.

• Excellent communication, project management, and cross-functional collaboration skills.

• Experience in a cleanroom or regulated manufacturing environment.

Personal Attributes:

• Integrity-Driven: Follows through on commitments and upholds the highest ethical and regulatory standards.

• Analytical & Detail-Oriented: Applies critical thinking and precision to solve problems and ensure compliance.

• Proactive: Anticipates risks and takes initiative to prevent issues before they arise.

• Collaborative Communicator: Works effectively across departments and communicates clearly with all stakeholders.

• Customer-Focused: Listens carefully and ensures quality solutions address real-world healthcare needs.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Manufacturing

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