Sr QA Specialist

Job Summary
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, the company employs over 300 highly‑skilled people in Kanata and Vancouver, British Columbia.

Location
On‑site in Kanata, Ontario.

Position Overview
The Senior 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 collaborates with cross‑functional teams—Engineering, Research and Development, Production, Quality Control, Procurement, Information Technology, and Human Resources—to ensure that products and processes meet or exceed regulatory requirements.

The role also focuses on continuous improvement by identifying opportunities for enhancing product quality and improving existing products. The specialist actively monitors current trends in cGMP regulations and brings relevant updates to the organization.

Your Day to Day as a Senior Quality Assurance Specialist

Coordinate one Medical Isotopes Quality System.

Ensure closure of system and product non‑conformances through the formal corrective action process, facilitating completion of requested actions.

Determine and establish appropriate quality procedures for controlling product and process quality, and assist the operating division in preparing quality and continuous improvement plans.

Provide independent guidance to Development groups for quality assurance requirements during all phases of a development project, consistent with the Medical Isotopes QA Team.

Initiate and follow through on actions improving efficiency of the assigned area by adjusting methods, procedures, systems, and working conditions.

Perform internal quality audits to maintain company quality objectives; conduct supplier audits as required.

Host or assist with customer audits and regulatory audits.

Establish and maintain quality data collection and analysis using appropriate information systems; 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 feedback and hosting audits, ensuring the company meets these requirements.

Provide Quality Assurance guidance and support to other departments and outside contractors.

May be required to perform drug or device product release activities and serve as backup support for the Quality Assurance Manager.

Perform other related duties as appropriate.

Required Qualifications

Undergraduate degree in Life Sciences or Engineering with 3–5 years of experience, or college diploma combined with significant industry experience, totaling 5 years in Quality Assurance, Quality Control, or a related area in a pharmaceutical or medical device environment. Advanced degrees considered an asset.

American Society of Quality (ASQ) certification (or equivalent) considered an asset.

Up‑to‑date knowledge of FDA, Health Canada, and European regulations to ensure compliance of Quality Systems, design, development, and validation practices.

In‑depth understanding of Good Manufacturing Practices (GMP) for Pharmaceuticals, Active Pharmaceutical Ingredients (APIs), medical devices, and ISO quality standards.

Sound judgment, problem‑solving, and analytical skills.

Ability to understand complex operations from a broad perspective.

Thorough knowledge of quality auditing methodology.

Capability to organize and direct efforts among many conflicting tasks; ability to train personnel at various levels, including managers, in quality‑related subjects.

Capability to build, facilitate, and coordinate teams for quality…