Job Description

Summary

We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health\xe2\x84\xa2 is our Purpose, and it\xe2\x80\x99s no small feat. It takes the imagination and passion of all of us\xe2\x80\x94from design and engineering to the manufacturing and marketing of our billions of MedTech products per year\xe2\x80\x94to 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\xe2\x80\x99ll be supported to learn, grow and become your best self. Become a maker of possible with us. Reports To: Associate Director, Quality Management Location: BD \xe2\x80\x93 Canada, Mississauga SUMMARY This position will provide Quality System support to Quality & Regulatory daily. The position will be responsible for the management of the BD \xe2\x80\x93 Canada quality systems and quality management initiatives, ensuring that BD \xe2\x80\x93 Canada complies to Canadian Drug, Natural Health Products, and Medical Device regulations and BD corporate quality management and compliance directives. ESSENTIAL DUTIES AND RESPONSIBILITIES

• Execute and maintain the BD quality (compliance) system with focus on document control, training, and corrective/preventative action program (including non-conformances).
• Establish and manage quality-regulatory compliance system and procedural requirements for drug product, natural health products and medical devices as per BD corporate policies and procedures, Health Canada regulations and the Canadian Food & Drugs Act and Regulations, Medical Devices Regulations and applicable ISO or other standards.
• Coordinate activities related to Quality System training (e.g. Corporate quality policies and procedures, Canadian quality policies and procedures, Drug Good Manufacturing Practices-GMP) for all associates as needed.
• Investigate and resolve quality issues involving drugs and medical devices.
• Responsible for the maintenance and continuous improvement of the various Quality System elements, monitoring and trending, and input into Management Review.
• Support the plan that identifies activities essential to successful integration of recent acquisitions with BD, while assuring business continuity, and supporting new products in development to expand the market.
• Play an active role in supporting BD corporate and BD Canada initiatives as well as alignment of improvement capability to continual improvement/optimization of elements of the Quality System beyond basic regulatory compliance to provide greater value to the business and its customers.
• Play an active role in supporting BD Corrective/Preventive Action System and, direct responsibility for root cause analysis, prioritizing and implementing corrective and preventive actions relevant to the effectiveness of the business Quality System to meet regulatory and business requirements.
• Provide support and/or act as back up for electronic systems (E.g. SAP, TrackWise, JDE), Complaints, and various other activities within the team as needed.

QUALIFICATIONS

• Strong verbal and written communication, negotiation and learning skills
• Strong working knowledge of the Canadian Food and Drug Act and Regulations, GMP Regulations and Guidances, Medical Devices Regulations, and ISO13485:2016
• Strong decision making, problem solving and trouble shooting skills
• Strong organization and time management skills

EDUCATION AND EXPERIENCE

• Bachelor of Science degree in life sciences or related discipline
• 2-3 years Quality experience in medical device and/or pharmaceutical industry
• Experience in SAP environment preferred
• Knowledge and experience with Canadian Medical Devices Regulations and Good Manufacturing Practices
• Knowledge and experience with ISO13485:2016

For certain roles at BD, employment is contingent upon the Company\xe2\x80\x99s 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\xe2\x80\x99s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It\xe2\x80\x99s also a place where we help each other be great, we do what\xe2\x80\x99s right, we hold each other accountable, and learn and improve every day. You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. And through the organization\xe2\x80\x99s investment in BD University, you will continually level up your tech skills and expertise. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you\xe2\x80\x99ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit https://bd.com/careers Great Place to Work\xc2\xae has certified our workplace culture based on your feedback in the Trust Index\xc2\xae survey, and we\'ve just published the news about us on their social media channels. You can check these out here. And if you think your friends and networks would be interested in knowing more about your workplace, sharing these posts is a great way to give them some insight! Becton Dickinson is an Equal Opportunity Employer. We encourage applications from individuals with a wide range of abilities and provide an accessible candidate experience. In accordance with the Accessibility for Ontarians with Disabilities Act, 2005, the Accessible British Columbia Act, 2021, and any other applicable legislation, including provincial human rights legislation, Becton Dickinson will provide reasonable accommodations to applicants with disabilities throughout the recruitment, selection, and/or assessment process. If selected to participate in the recruitment, selection, and/or assessment process, please inform us of any accommodation(s) you require by contacting HR at 1-855-234-3577. PDN

Primary Work Location

CAN Mississauga - Derry Road West

Additional Locations

Work Shift