Sr Quality Manager, Failure Analysis

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 maker of possible with us.

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.

How you will make an impact :

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 in order 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

What we look for : (Required)

Bachelor's Degree in engineering and 8+ years of medical device industry experience including :

Failure Analysis tools, technologies and methodologies

Quality Engineering, Quality Management, R&D within the medical device industry

Demonstrated track record in management of technical and / or engineering disciplines

What else we look for : (Preferred)

Experience working in a regulated industry

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.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and / or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

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 health.