Job Description Summary

The Quality Excellence leader is a globally minded, cross-functional leader responsible for driving the resolution of complex, high-impact quality issues in a regulated medical device environment. This role is accountable not only for resolving issues reactively but also for proactively identifying quality risks and systemic gaps across products, processes, and geographies.
With a strong foundation in root cause analysis, CAPA management, and continuous improvement, this role partners across sites, business units, and regions to ensure quality issues are addressed with rigor, transparency, and global alignment. The Quality Excellence leader is expected to take proactive ownership of problem statements and lead them to resolution while strengthening the global Quality Management System (QMS).

Job Description

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.
• 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.

Education, Experience

• 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.

Skills

• Ability to 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
• Participate in global quality forums
• Drive enterprise-level actions that address root causes across products, sites, or platforms—not just single events.
• contribute to the maturity of the QMS by standardizing investigation methods
• Lead high-risk CAPAs from start to finish
• Fluent in english

Other

• Travel 25% to customer locations or BD manufacturing locations

Required Skills

Optional Skills

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Primary Work Location

HUN Kornye - Uveggyar

Additional Locations

Work Shift