Job Description Summary

How about becoming a maker of possible?

For more than 125 years, we’ve pursued our Purpose of advancing the world of health™. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities – For people today, tomorrow and beyond. Become a maker of possible with us!

Pharmaceutical Systems (PS)

With innovative pre-fillable syringes, self-injection systems, safety systems and needle technologies, the Pharmaceutical Systems (PS) team offer an extensive selection of solutions designed to protect, package and deliver drug therapies.

Job Description

Quality Excellence Leader

Main missions

Root Cause Analysis & Investigation Leadership

• Lead cross-functional investigations into significant quality issues, nonconformances, audit observations, and customer complaints across BD sites.
• Apply structured problem-solving tools (e.g., 5 Whys, Ishikawa, Fault Tree, DMAIC) to identify root causes and develop robust, data-backed solutions.
• Capacity to represent the Quality function in global meetings and regulatory inspections.
• Ensure investigation processes are harmonized globally and aligned with regulatory and internal expectations.

Proactive Risk Identification & Systemic Improvement

• Use trending, metrics, and global issue escalation processes to proactively detect emerging quality risks before they impact product or compliance.
• Drive enterprise-level actions that address root causes across products, sites, or platforms—not just single events.
• Participate in global quality forums to share lessons learned and drive harmonized improvements across the BD network.

Corrective & Preventive Action (CAPA) Ownership

• Lead high-risk CAPAs from start to finish, ensuring actions are effective, timely, and preventative in nature.
• Support global CAPA governance by advising sites on CAPA structure, risk justification, effectiveness checks, and audit readiness.
• Track and improve CAPA cycle time, recurrence rates, and overall effectiveness across the business.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Quality, or a related technical field.
• 5–10 years of experience in Quality, Manufacturing, or Engineering within a regulated industry (medical devices, pharmaceuticals, diagnostics, etc.).
• Demonstrated success leading root cause investigations and CAPAs in a global, matrixed environment.
• Strong understanding of global regulatory requirements (FDA, ISO 13485, EU MDR, MDSAP).
• Excellent communication and facilitation skills, with the ability to influence across levels and cultures.
• Comfortable leading complex issue resolution across time zones, business units, and functions.
• Fluent in English
• Travel 25% to customer locations or BD manufacturing locations.

“BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”

Required Skills

Optional Skills

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Primary Work Location

MEX Cuautitlan Izcalli

Additional Locations

Work Shift