Sr 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 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 Sr. Quality Assurance Specialist plays a key role in developing, maintaining, and evolving the Quality Assurance Systems for products and processes to ensure compliance with various regulatory bodies and standards, including FDA, Health Canada, ISO 9001, ISO 13485, and European CE Mark requirements for drugs and medical devices. This role will collaborate with cross-functional teams, including Engineering, Research and Development, Production, Quality Control, Procurement, Information Technology, and Human Resources, to ensure that products and processes meet or exceed regulatory requirements.

This role also focuses on continuous improvement by identifying opportunities for enhancing the quality of products in development and improving existing products. You will actively monitor current trends in cGMP regulations and bring relevant updates to the attention of the organization.

• Typically, responsible for the coordination of one Medical Isotopes Quality Systems (as described above).
• Ensure closure of system and product non-conformances through the use of the formal corrective action process, and facilitates completion of requested actions.
• Determine and establish the appropriate quality procedures for controlling product and process quality. Provide leadership and assist the operating division in preparing quality plans and continuous improvement plans for their work areas.
• Provides independent guidance to Development groups for quality assurance requirements (regulatory requirements and industry best practices) in all phases of a development project. Guidance must be consistent with the direction of the Medical Isotopes QA Team.
• 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. Performs supplier audits, as required.
• Host or assist with customer audits and assist with 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.
• May be required to 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 3-5 years experience, or College diploma (may be considered when combined with…