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.

Welcome to BWXT
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.

Location:

On-site in Kanata, Ontario

Position Overview:

The Quality Assurance Specialist 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. This role reports into the Quality Engineering and Validation Department.

Your Day to Day as a Quality Assurance Specialist:

• Work with the Validation team to determine and establish the appropriate validation philosophies for qualification of equipment, cleaning, computerized systems, facilities and processes.
• Support the Validation and development groups with review/approval of validation activities, deficiencies, deviations and 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 and validation 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.
• Supporting customer audits as required 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 if required.
• Performs other related duties as appropriate to this level.

Required Qualifications:

• Normally an undergraduate degree in Engineering with 2-5 years experience in Quality Assurance or Validation or other relevant area in pharmaceutical, medical device environment.
• Ability to obtain Ontario Professional Engineering designation is 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 auditing methodology.
• excellent organizational and communication skills (verbal and written).
• Ability to analyze data, trend, and determine corrective actions.
• Demonstrated proficiency in computer systems.

WHAT WE CAN OFFER YOU: Ensuring the well-being of our employees is our priority and we offer comprehensive and competitive benefits for our employees and their families.

• Comprehensive Health Benefits – Including health, dental, vision, and disability coverage to keep you feeling your best.
• Secure Your Future – Defined Contribution Pension Plan and an optional Company-matched retirement savings plans (RRSP/TFSA/EPSP)
• Work-Life Balance – Flexible hybrid schedules and compressed workweek option available
• Help Grow Our Team – Earn generous referral bonuses with our two-tiered
• Employee Referral Program ($1,500 and $3,000!).
• Invest in Your Education – Up to $5,250 USD per year through our Educational Refund Plan.
• Professional Development – Gain access to training, certifications, and growth opportunities to advance your career.
• Your Wellness Matters – Enjoy gym membership discounts and access to mental health support programs.
• A Welcoming Workplace – Join a diverse, inclusive, and supportive culture that celebrates you.
• Fun & Connection – Engage in team-building activities organized by our Social Committee.Ready to grow with us?

Apply now and let’s build something amazing together!

At BWXT, we are committed to a fair, transparent, and inclusive hiring process.

As part of our recruitment practices, we use artificial intelligence (AI) tools to assist with screening and evaluating applicants. These tools support our efforts to make consistent and equitable hiring decisions.

The base salary range for this position in Ontario (CA-ON)at the start of employment is expected to be between $$73,000.00 and $$106,000.00 per year. However, the base salary offered is based on local job market factors and may vary further depending on factors specific to the selected job candidate, such as job-related knowledge, skills, experience, and other objective business considerations. Subject to these considerations, the total compensation package for this position may also include other elements, such as an annual cash incentive in addition to a full range of medical, retirement, and/or other benefits. Details of participation in these benefit plans will be provided at such time the selected job candidate receives an offer of employment.

Learn more about how BWXT employs nuclear technology to solve some of the world’s most important problems. BWXT’s capabilities video showcases our innovation in commercial nuclear power, addressing climate change, as well as our advanced nuclear medicine products treating patients around the world. We are People Strong. Innovation Driven.

BWXT Medical Ltd. embraces diversity of thought, values individuality, encourages new perspectives and provides equal opportunity in employment for all qualified employees and applicants without regard to race, national or ethnic origin, colour, religion, age, sex, sexual orientation, marital status, family status, disability, a conviction for which a pardon has been granted or a record suspended or any other category protected by federal law. BWXT Medical Ltd. is committed to fostering an accessible, fair, and inclusive environment where all employees are able to access goods while being respected and supported. If you require accommodations during the application or interview process, please advise us as soon as possible so appropriate arrangements can be made. If you require information in a format that is accessible to you, please contact Human Resources.