QA Manager - Medical Devices



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Branch Information

Markham, ON - (CAN) 7500-7560 Woobine Ave Unit F ON Markham , ON - L3R 1AB Phone : 905-695-1271



Job Description

QA Manager position with a global leader in the medical device and biotechnology sector - based in the York Region, Ontario. Competitive comp package offered including extensive benefits, perks and bonus. Position available due to growth and expansion!

Position Overview: The Quality Associate Manager is responsible for managing the activities of a quality team in support of the current and future Quality Management System. The Quality Associate Manager champions, develops and promotes quality activities to meet regulatory and quality requirements while supporting business goals and improving customer satisfaction. The Quality Associate Manager will be accountable for developing and executing solutions relating to quality and ensuring the Quality Management System is implemented and maintained effectively in the organization.

Job Duties:

Manage and lead the quality team by exhibiting all corporate and divisional expectations of people leaders to include, but not be limited to developing employees, managing employee performance/engagement, promoting continuous improvement, managing department business/communications, driving organizational alignment, selecting/retaining talent, and consistently modelling excellence, integrity, and accountability.

Champion the development, implementation and continuous improvement of a Quality Management System to meet and/or harmonize with global Quality Systems, Canadian Medical Devices Regulations, Canadian Food and Drugs Act, FDA, ISO 13485, as applicable. Develop and lead QMS training programs.

Ensure the Quality Management System is effectively being maintained in the organization.

Manage and champion quality systems and tools, such as CAPA, Non- Conformance Reporting, Change Notice, Audit etc.

Manage and oversee processes relating to product quality throughout product lifecycle, including complaint handling and Mandatory Problem Reports.

Develop and execute strategies for addressing quality issues. Develop and revise Policies, SOP and WI as needed.

Oversee the maintenance and control of quality documents, business documents, labeling and training material. Champion continuous development in these processes.

Monitor key performance indicators and prepare progress reports for Quality Review meetings and for senior management.

Job Requirements:

Minimum of 5 years experience within Medical Device or Pharmaceutical environment, with strong concentration in quality systems and/or quality assurance is required.

Minimum 2 years of supervisory experience is required.

Bachelor of Science, Engineering, or Scientific discipline

Demonstrated knowledge of Quality (Audit, Change Control, NC,CAPA, Deviations, etc)

Must possess the ability manage multiple projects, prioritize and meet competing deadlines.

Must have demonstrated knowledge of Canadian Medical Devices Regulation, FDA Quality System Regulations and ISO 13485.

Experience with quality system development, implementation and/or revision is preferred.

Bilingual in English/French is an asset


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