JOB DESCRIPTION

We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
The Quality Management Associate is primarily responsible for ensuring that BD Canada maintains a robust and effective complaint handling system in compliance with applicable BD procedures, the Canadian Medical Devices Regulations, the Food and Drugs Act and Regulations, and Canadian GMP requirements. Additionally, the role supports BD’s broader objectives by contributing to initiatives that create customer value and address key elements critical to business success.

EDUCATION AND EXPERIENCE REQUIRED

• Bachelor’s degree required.
• 2 years quality experience in medical device and/or pharmaceutical industry

KNOWLEDGE AND SKILLS REQUIRED

• Excellent verbal and written communication skills
• Customer-focused – Committed to meeting the needs and expectations of both internal and external customers
• Strong decision-making and problem-solving abilities – Demonstrate critical thinking, effective troubleshooting, and timely decision-making
• Highly organized with strong time management skills – Capable of managing multiple tasks efficiently
• Results-driven – Consistently achieves goals and delivers outcomes
• Continuous learner – Possesses the functional, technical, and job-specific knowledge to perform at a high level and adapt to new challenges

PREFERRED QUALIFICATIONS

• Bachelor’s in science, Life Sciences, Engineering or related discipline preferred.
• Experience in complaint handling activities preferred
• Experience in SAP or TrackWise environment preferred
• Knowledge and experience with Good Manufacturing Practices and Canadian Medical Devices Regulations preferred.
  At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
  For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

• Product Quality Complaints - Responsible for managing and overseeing customer complaints from system entry through to closure:
• Collaborate with the global complaints network to enhance the complaints handling process, including system improvements, process efficiency, and reporting
• Evaluate complaints for reportability to Health Canada and prepare Mandatory Problem Reports (MPRs) as required
• Assess and report Foreign Mandatory Problem Reports (FMPRs) when applicable
• Prepare and communicate investigation results to customers
• Liaise with internal stakeholders, including marketing and field associates
• Respond to inquiries from Health Canada
• Manage the return process for complaint samples and coordinate replacement product shipments to customers
• Manage the return process for complaint samples and coordinate replacement product shipments to customers
• Quality Compliance
• Use metrics and reporting tools to monitor processes, drive continuous improvement, and conduct investigations as needed
• Maintain complaint management procedures in compliance with corporate policies and Health Canada regulations; provide training to relevant associates
• Ensure non-conformances are properly addressed, with root causes identified and corrective actions implemented to prevent recurrence
• Participate in internal and external audits, provide necessary documentation, and ensure timely closure of audit actions