Sr. Manager, Quality Engineering

Usa Ca - Irvine Laguna Canyonsenior

OtherQuality Engineering

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Quick Summary

Key Responsibilities

Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule,

Technical Tools

OtherQuality Engineering

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.

The Senior Quality Manager, Failure Analysis will lead a team of engineers and technicians responsible for conducting thorough investigations into product failures, identifying root causes, and implementing corrective actions to ensure product reliability and quality. This role involves managing cross-functional teams, analyzing data, developing testing protocols, using advanced failure analysis tools and driving continuous improvement initiatives. Strong leadership skills, analytical expertise, attention to detail, and a background in engineering, with experience conducting failure analysis, are essential for success in this position.

Responsibilities

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Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re-design/design on new products and/or processes. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
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Develop failure analysis tools and processes for ongoing root cause analysis, focused on proactive actions to improve the overall quality of our products.
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Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities.
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Develop a robust talent development plan in alignment with functional growth strategies of the department Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity
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Lead the implementation of CAPA program including training, approvals, and system effectiveness
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Interact with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; lead a cooperative effort among members of a project team Participate and present at meetings with internal and external representatives
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Resolve operational and scheduling issues
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Other incidental duties

Bachelor's Degree in engineering.
8+ years of medical device industry experience in Failure Analysis tools, technologies and methodologies, complaint investigation and handling, strong data analytical experience,
Quality Engineering, Quality Management, R&D
Demonstrated track record in management of technical and/or engineering disciplines

Experience working in med device
Six Sigma Certification
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 addressing issues with impact beyond own team based on knowledge of related disciplines
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
Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business
Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Dedicated to quality client service and pro-active and responsive to client needs.

What We Offer

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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.