QA Manager

Role overview

Responsibilities

• Ensure product lifecycle and distribution-region compliance with applicable Health Canada, drug GMP, and ISO regulations.
• Liaise with product divisions, global service organizations, suppliers, manufacturing, and other partners to support quality and customer satisfaction.
• Identify and manage continuous improvement projects.
• Support product evaluations for quality assurance and regulatory compliance.
• Assist with planning product design, testing, inspection, and process validations.
• Resolve product and production quality issues with internal and external customers in a timely manner.

Qualifications

• BSc required in Engineering, Science, or a technical field.
• At least four years of related experience with medical device or drug combination product platforms, design controls, risk management, and regulated requirements.
• Experience with drug GMPs and broad knowledge of relevant standards, including Health Canada, ISO 13485, ISO 14971, MDSAP, and MDR.
• Proficiency in analyzing and reporting data to identify issues, trends, or exceptions and drive improvements.
• Ability to coordinate concurrent projects, competing priorities, and critical deadlines.
• Advanced Microsoft Excel skills required.
• At least two years of supervisory or managerial experience preferred.
• Medical device industry experience, particularly dental, operating room/surgical instruments, or orthopaedics, preferred.

Compensation

• Anticipated annual salary range is $114,600 to $171,800.

Employee value proposition

• Benefits include insurance, RRSP matching, paid vacation and personal days, employee assistance resources, training and career growth programs, education support, fitness subsidy, and recognition programs.

About Medline Canada