QA Specialist

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 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‑month position is responsible for the design and maintenance of the Quality Assurance System procedures or products and their compliance with the requirements of 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.

• Coordinate one Medical Isotopes Quality System.
• Determine and establish appropriate quality procedures for controlling product and process quality and assist divisions in preparing quality plans and continuous improvement plans.
• Support development groups with review/approval of validation activities and change control.
• Perform internal quality and supplier audits to ensure that company quality objectives are maintained.
• Initiate and follow through on actions to improve efficiency of the assigned area of responsibility, adjusting methods, procedures, systems and working conditions.
• 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 Management Review.
• Provide training on Quality Assurance procedures for internal groups, including 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 and hosting customer audits, ensuring the company is working to meet these requirements.
• Provide Quality Assurance guidance and support to other departments and outside contractors.
• Perform drug or device product release activities; may provide backup support for the Quality Assurance Manager position.
• Perform other related duties as appropriate.

• An undergraduate degree in Life Sciences or Engineering with 2‑5 years experience in Quality Assurance or Quality Control or a related area in a pharmaceutical or medical device environment; advanced degrees considered an asset.
• Certification in quality auditing or ASQ certification (or equivalent) considered an asset.
• Maintain up‑to‑date knowledge of FDA, Health Canada and European regulations to ensure quality systems, design and development and validation practices remain current and compliant.
• In‑depth understanding of GMP regulations for Pharmaceuticals, APLs, medical devices and ISO quality standards.
• Possess sound judgment, problem‑solving and analytical skills.
• Ability to understand complex operations from a broad perspective.
• Thorough knowledge of quality auditing methodology.
• Excellent organizational and communication skills (verbal and written).
• Ability to analyze data, trend and determine corrective actions.
• Demonstrated proficiency in computer systems.

• Comprehensive Health Benefits – health, dental, vision and disability coverage.
• Defined Contribution Pension Plan and optional company‑matched retirement savings plans (RRSP/TFSA/EPSP).
• Flexible hybrid schedules and compressed workweek option.
• Generous referral bonuses with a two‑tiered Employee Referral Program ($1,500 and $3,000).
• Educational Refund Plan – up to $5,250 USD per year.
• Professional development – training, certifications and…