QMS Quality Compliance Lead (ISO/GMP)

Stryker Group; Hamilton; On-site; CAD 60,000 - 90,000; Full time

Job summary

A leading medical device company in Hamilton, Ontario, is seeking a Quality Assurance professional to oversee the development of its quality management system. Responsibilities include ensuring compliance with ISO standards and Canadian regulations, supporting audit processes, and leading improvement initiatives. The ideal candidate must possess a university degree, at least 3 years of experience in regulatory affairs or quality assurance, and strong communication skills. This role champions the company values and promotes a culture of quality and compliance.

Qualifications

• Minimum 3+ years’ experience in regulatory affairs and/or quality assurance.
• Experience in regulated environment and interaction with auditing authorities required.
• Project management experience preferred.

Responsibilities

• Support Quality Management System compliance with regulatory requirements.
• Contribute to the development of the QMS for business needs.
• Liaise with external assessment bodies and health authorities.

Skills

Working knowledge of ISO 9001 requirements

Strong computer skills (Excel, Word, Power Point)

Strong oral and written communication skills

Highly organized and able to prioritize tasks

Education

University Degree

Post-graduate diploma in Regulatory Affairs or Quality Assurance

Tools

Trackwise

ComplianceWire

Job description

A leading medical device company in Hamilton, Ontario, is seeking a Quality Assurance professional to oversee the development of its quality management system. Responsibilities include ensuring compliance with ISO standards and Canadian regulations, supporting audit processes, and leading improvement initiatives. The ideal candidate must possess a university degree, at least 3 years of experience in regulatory affairs or quality assurance, and strong communication skills. This role champions the company values and promotes a culture of quality and compliance.