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

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. 

Responsibilities:

This role must develop strategic quality programs to oversee and foster the following areas and represent QMS expert-level leadership and guidance for teams.

• QMS architecture: QMS certificate change notifications; change in scope of activities performed at sites; and site transfers

• QMS compliance: front room host for external audits and inspections; QMS expert to prep SMEs for front room; Management Review host; identifying QMS gaps in organizational structure, competency, or technical areas; implementing solutions to close QMS gaps, including but not limited to CAPAs, projects, workshops, and training; authoring CAPA investigations

• QMS harmonization activities: MMS lead for Inspire Quality program to harmonize processes with Global expectations and between MMS platforms (including Class I/II medical devices and non-medical devices)

• QMS integration activities: QMS impact assessments for integrating acquisitions, platforms, products, sites, etc.; due diligence activities for potential acquisitions

Required Qualifications:

• A BS degree in a technical field (Engineering, Science, Math/Stat)

• Minimum 8 years experience in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.

• Demonstrated expert-level knowledge of QMS.

• Ability to travel domestically and internationally, up to 25%

• Strong leadership skills with demonstrated ability to deliver excellent results

• Strong project management, team skills, and influential management

• Experience leading or supporting FDA and/or Notified Body inspections

• Excellent communication skills (up, down, and outward)

Preferred Qualifications:

• Experience in Regulatory Affairs preferred.

• Experience in metrics, data analytics, and/or statistical analysis preferred.

• ASQ certifications CQE, CSQE, CRE, CMQ/OE, CSSGB and/or CSSBB highly desired.

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. At BD, you’ll discover a culture