QA Specialist

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BWXT Medical Ltd. is a trusted source for the development and manufacture of nuclear medicine for biotechnology, life sciences, pharmaceutical companies and academia partners. Headquartered in Kanata, Ontario, BWXT Medical Ltd. employs over 300 highly-skilled people in Kanata and Vancouver, British Columbia.

We believe in empowering our employees and cultivating a dynamic workplace that fosters growth and collaboration. Whether you’re an experienced professional or just starting your career, you'll find opportunities to challenge yourself, learn from seasoned experts, and contribute to nuclear innovation. We required a diverse range of skills to support our work in the markets that drive our business and welcome candidates from all backgrounds and life stages who are passionate about making a difference.

On-site in Kanata, Ontario

The Quality Assurance Specialist - 10 months 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.

• Typically, responsible for the coordination of one Medical Isotopes Quality Systems (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 ensure that company quality objectives are maintained.
• Initiate and follow through on actions relating to improved efficiency of assigned area of responsibility by adjusting methods, procedures, systems and working conditions.
• Perform internal quality audits to ensure that company quality objectives are maintained.
• Support customer and regulatory audits.
• Establish and maintain quality data collection and analysis using appropriate information systems to improve product design, manufacturing, supplier and quality systems and report at the Management Review as required.
• Provide training on Quality Assurance procedures for internal groups such as:
  Production, Quality Control, Research and Development and other personnel. Also provide general GMP/Quality System training, as required.
• Develop, plan and maintain all necessary QA Systems, procedures and documentation to meet applicable quality and regulatory standards.
• Identify customer requirements by monitoring customer feedback, hosting customer audits and ensure that the company is working to meet these requirements.
• Provides Quality Assurance guidance and support to other departments and outside contractors.
• Perform drug or device product release activities. May be responsible to provide back-up support for the Quality Assurance Manager position.
• Performs other related duties as appropriate to this level.

• Normally an undergraduate degree in Life Sciences or Engineering with 2-5 years experience in Quality Assurance or Quality Control or other relevant area in pharmaceutical, medical device environment. Advanced degrees would be considered an asset.
• Certification in quality auditing, American Society of Quality (ASQ) certification (or equivalent) is considered an asset.
• Must maintain up-to-date knowledge with respect to regulations for the FDA, Health Canada, and Europe to ensure Quality Systems, design and development and Validation practices are current and compliant.
• In-depth understanding of the Good Manufacturing Practices (GMP) regulations for Pharmaceuticals, Active Pharmaceutical Ingredients (APls), medical devices and ISO quality standards.
• Possess sound judgment, problem solving and analytical skills.
• Must have the ability to understand complex operations from a broad perspective.
• Thorough knowledge of quality…