LATAM Regional Quality Integration Leader

BD; São Paulo; On-site; BRL 350,000 - 500,000; Full time

Job summary

BD is seeking a LatAm Global Quality Regional Integration Leader based in São Paulo to drive QMS integration across LatAm countries and manage regional post-market quality activities, including field actions and recalls. You will collaborate with Regulatory, Supply Chain, and Operations teams to ensure regulatory compliance and continuous improvement.

The role leads regional quality programs, harmonizing processes with global teams and overseeing agreements with 3PLs and distributors while

Responsibilities

• Support the identification and implementation of quality requirements for the establishment and expansion of global quality presence at LatAm region.
• Ensure the implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes in compliance with applicable regulatory requirements.
• Ensure QMS certification (ISO 13485, ISO 9001) as appropriate
• Establish regional post-market quality activities, including customer complaint handling, adverse event reporting, field actions, corrections, removals, and recalls, ensuring compliance with applicable regulatory requirements and company procedures.
• Establish, maintain, and oversee Quality Agreements with Third-Party Logistics providers (3PLs), distributors, and other external partners.
• Establish management and execution of field actions, corrections, removals, recalls, and product safety notifications, including coordinating activities with Regulatory Affairs, Supply Chain, Commercial, and Operations teams.
• Ensure compliance with applicable regulations and requirements.
• Participate in internal and external audits, inspections, and regulatory agency interactions.
• Collaborate with global and regional quality teams to harmonize processes, share best practices, and improve the effectiveness of post-market quality programs.
• Perform other duties and responsibilities as assigned.

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

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.

Job Description

The LatAm Global Quality Regional Integration Leader is accountable for supporting the transition planning for Quality Regional teams at LatAm region, ensure integration of Quality Management System on participant countries, including when applicable, ISO certification. Support development, improvement and implementation of the post-market regional management. This position provides quality leadership and guidance to project teams and the quality network, supporting process optimization and continuous improvement initiatives. The role is directly accountable for multiple projects within the department and may also have responsibility for programs spanning multiple sites.

• Support the identification and implementation of quality requirements for the establishment and expansion of global quality presence at LatAm region.
• Ensure the implementation, maintenance, and continuous improvement of Quality Management System (QMS) processes in compliance with applicable regulatory requirements.
• Ensure QMS certification (ISO 13485, ISO 9001) as appropriate
• Establish regional post-market quality activities, including customer complaint handling, adverse event reporting, field actions, corrections, removals, and recalls, ensuring compliance with applicable regulatory requirements and company procedures.
• Establish, maintain, and oversee Quality Agreements with Third-Party Logistics providers (3PLs), distributors, and other external partners.
• Establish management and execution of field actions, corrections, removals, recalls, and product safety notifications, including coordinating activities with Regulatory Affairs, Supply Chain, Commercial, and Operations teams.
• Ensure compliance with applicable regulations and requirements.
• Participate in internal and external audits, inspections, and regulatory agency interactions.
• Collaborate with global and regional quality teams to harmonize processes, share best practices, and improve the effectiveness of post-market quality programs.
• Perform other duties and responsibilities as assigned.

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

BRA Sao Paulo - Chacara Santo Antonio