Sr Dir, Quality Engineering

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BD is one of the largest global medical‑technology companies in the world. Advancing the world of health™ is our Purpose, and it takes the imagination and passion of all of us—from design and engineering to manufacturing and marketing of our billions of Med Tech 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 allows us to continually evolve. Join us to discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Manage a team to ensure smooth and continuous operations in quality.

• Direct a team responsible for quality engineering activities (e.g., process and test methods validations, product transfer, process improvements, non‑conformance investigation, corrective action, product disposition, complaint analysis, risk management) with overall responsibility for developing quality processes, staffing, planning, budgeting, aligning priorities, performance management, and working through managers to achieve results. Drive a culture focused on quality and business results, creating an environment that fosters employee motivation and engagement.
• Plan, prioritize, and direct strategic program activities including product, process, and quality projects using engineering methods (e.g., Six Sigma and LEAN) to align with applicable compliance standards. Lead in identifying risk, developing complex mitigation strategies, resolving issues, and collaborating with cross‑functional groups.
• Collaborate with leadership to develop operational strategy and partner with cross‑functional groups/resources to achieve tactical execution of business objectives.
• Provide technical guidance to cross‑functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity, including root‑cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, and initiation and approval of product/process changes and disposition of discrepant material.
• Identify and lead efforts to optimize quality engineering processes and define and implement core competencies by assessing business needs and developing solution options.
• Develop robust talent development and succession planning in alignment with functional growth strategies across the quality organization.
• Collaborate and align with network and COE teams in driving standardized programs and/or processes.
• Provide quality engagement to audits, including resources support, technical and procedural expertise, presentation of information, and effective resolution of issues.
• Other incidental duties.

Bachelor's Degree in a related field with experience in engineering. Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry or equivalent. Demonstrated track record in management of technical and/or engineering disciplines. Experience working in a regulated industry is preferred.

• Proven successful project management leadership skills.
• Proven expertise in Microsoft Office Suite and related systems.
• Excellent problem‑solving, organizational, analytical and critical‑thinking skills with high discretion/judgment.
• Excellent documentation and communication skills and interpersonal relationship skills, including negotiation and relationship management.
• Expert understanding of engineering procedures and quality engineering processes.
• Expert knowledge of FDA, GMPs and ISO/EN regulatory requirements.
• Expert knowledge of design of experiments, process capability studies, FMEA, SPC, industrial statistical methods and Lean Manufacturing.
• Knowledge of financial acumen as it relates to the business and quality engineering.
• Demonstrated ability to direct teams and provide coaching and feedback, including hire/fire authority and partnership with HR.
• Ability to…