Job Description
Location
On-site in Kanata, Ontario
Position Overview
The Quality Assurance Specialist position is responsible for design and maintenance of the Quality Assurance System procedures or products and their compliance with the requirements of the various regulatory bodies and Standards such as the FDA, Health Canada, ISO 9001, ISO 13485 and the European requirements for Drugs and devices which may include CE Mark requirements.
Your Day To Day
- Typically, responsible for the coordination of one Medical Isotopes Quality System as described above.
- Determine and establish the appropriate quality procedures for controlling product and process quality. Provide guidance and assist the operating division in preparing quality plans and continuous improvement plans for their work areas.
- Support development groups with review/approval of validation activities, change control.
- Perform internal quality and supplier audits to ...