Sr QA Specialist

Sr QA Specialist

Company: BWXT Medical Ltd.

Location: On-site in Kanata, Ontario.

Senior Quality Assurance Specialist responsible for developing, maintaining, and evolving Quality Assurance Systems for products and processes to ensure compliance with FDA, Health Canada, ISO 9001, ISO 13485, and European CE Mark requirements for drugs and medical devices. Works cross‑functionally with Engineering, R&D, Production, QC, Procurement, IT, and HR to meet regulatory and quality objectives.

This role focuses on continuous improvement, identifies opportunities for enhancing product quality, monitors cGMP regulation trends, and ensures current regulatory compliance.

• Coordinate Medical Isotopes QA system activities and ensure system and product non‑conformances are closed via formal corrective action.
• Determine and implement suitable quality procedures for controlling product and process quality.
• Provide leadership and assistance to the operating division in developing quality plans and continuous improvement plans.
• Offer independent guidance to Development groups on regulatory and industry best practices.
• Initiate actions for process efficiencies by adjusting methods, procedures, systems.
• Perform internal quality audits; conduct supplier audits as needed.
• Assist with customer and regulatory audits.
• Maintain quality data collection and analysis; report to Management Review.
• Deliver QA training to Production, QC, R&D, and other personnel.
• Develop, plan and maintain QA systems, procedures and documentation to meet applicable standards.
• Monitor customer feedback and ensure company meets customer requirements.
• Provide QA support to other departments and external contractors.
• Support drug or device release activities; backup QA Manager as required.
• Perform other related duties as appropriate for this level.

• Undergraduate degree in Life Sciences or Engineering (or equivalent college diploma with >5 years experience) and 3‑5 years in QA/QC or related area in pharmaceutical or medical devices.
• ASQ certification (or equivalent) is an asset.
• Up‑to‑date knowledge of FDA, Health Canada, and European regulations and GMP/ISO requirements.
• Strong understanding of Good Manufacturing Practices for Pharma, APIs, medical devices, ISO 9001/13485.
• Excellent judgment, problem‑solving, analytical skills.
• Ability to understand complex operations and prioritize conflicting tasks.
• Proficient in QA auditing methodology.
• Experience training individuals of varying responsibility levels.
• Experience in building/leading quality improvement projects and teams.
• Knowledge of QA techniques including statistical analysis, root cause analysis, Lean Six Sigma.

Compensation: Base salary range $85,000‑$126,000 per year, contingent on local market and experience. Additional annual incentive and full benefits package provided.

• Comprehensive Health Benefits – health, dental, vision, disability.
• Defined Contribution Pension Plan with optional company‑matched retirement savings.
• Flexible hybrid schedules and compressed workweek options.
• Referral bonuses (Tier 1 $ 1,500, Tier 2 $ 3,000).
• Educational Refund Plan – up to $5,250 USD per year.
• Training, certification, and career development opportunities.
• Gym membership discounts and mental health support programs.
• Diverse, inclusive, supportive culture.
• Team‑building social committee activities.

BWXT Medical Ltd. embraces diversity of thought, values individuality, and encourages new perspectives. It provides equal opportunity for all qualified employees and applicants regardless of race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability or any federally protected category. Please contact Human Resources for accommodations or accessible interview materials.