Sr Dir, Quality Engineering

Job Description Summary

Job Description

We are the makers of possible

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.

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'll be supported to learn, grow and become your best self. Become a makerof possible with us.

Manage team to ensure smooth and continuous operations in quality.

Key Responsibilities:
• Direct a team with responsibilities 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 of developing quality processes, staffing, planning, budgeting, aligning priorities, performance management, and working through managers to achieve results. Drive a culture that is focused on quality and business results. Create 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 methods) to align with applicable compliance standards. Lead in identifying risk, developing complex mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups.
• Collaborate with leadership to develop operational strategy. 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, 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 to develop, propose and implement 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

Education and Experience:
Bachelor's Degree in in related field with related experience in engineering required and skill levels exceeding the requirements of the Senior Manager or equivalent work experience Required and
Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry or equivalent work experience Required and Demonstrated track record in management of technical and/or engineering disciplines or equivalent work experience Required. Experience working in a regulated industry or equivalent work experience Preferred
Additional Skills:
• Proven successful project management leadership skills
• Proven expertise in both Microsoft Office Suite and related systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems
• Expert understanding of related aspects of quality engineering processes and/or systems
• Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
• Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing