Sr. Manager, Quality Engineering

Regulatory Jobs; Irvine (CA); Presencial; USD 165.000 - 263.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Six Sigma training

Descripción de la vacante

BD, a global medical technology leader, is seeking a Senior Quality Manager for Failure Analysis in Irvine, CA. Lead a team of engineers and technicians to investigate product failures, identify root causes, and implement corrective actions ensuring reliability and quality across medical devices.

Responsibilities include developing failure analysis tools, CAPA program leadership, and coordinating cross-functional efforts with a focus on Six Sigma/LEAN methods and regulatory compliance (FDA, GMP,

Formación

• 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

Responsabilidades

• Manage project activities with 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.
• Develop failure analysis tools and processes for ongoing root cause analysis, focused on proactive actions to improve the overall quality of our products.
• Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities.
• 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
• Lead the implementation of CAPA program including training, approvals, and system effectiveness
• 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
• Resolve operational and scheduling issues
• Other incidental duties

Conocimientos

Six Sigma Certification

Project management

Quality engineering

Data analysis

Leadership

Regulatory knowledge FDA GMP ISO

Educación

Bachelor's Degree in engineering

Herramientas

Microsoft Office Suite

Descripción del empleo

We are the people who give possibilities purpose

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.

Job Description

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 include but are not limited to:

• 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




• Develop failure analysis tools and processes for ongoing root cause analysis, focused on proactive actions to improve the overall quality of our products.




• Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities.




• 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




• Lead the implementation of CAPA program including training, approvals, and system effectiveness




• 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




• Resolve operational and scheduling issues




• Other incidental duties

Minimum education and experience required:

• 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

Minimum Knowledge, Skills, or Abilities (KSA’s):

• 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 elevate 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.

Why Join Us?

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.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA CA - Irvine Laguna Canyon

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under \"Our Commitment to You\".

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$164,600.00 - $263,400.00 USD Annual