Site CAPA Leader​/Quality Culture​/Systems

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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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 Med Tech 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.

RESPONSIBILITY:

• Essential responsibilities include but are not limited to:

• Owner of the CAPA process

• Good understanding of the Manufacturing processes and Quality System.

• Promote/ Leading / mentoring / conducting quality improvement projects thru continuous improvement initiatives.

• May obtain Green/Black Belt Certification.

• Assist in the acceptance and validation of process equipment.

• Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost.

• Assume a role of leadership in analyzing and resolving issues, which lead to strengthening the CAPAs effectiveness.

• Stay informed as the latest requirements of federal regulations and corporate policies regarding medical devices.

• Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements.

• Provide support and guidance on quality/ process improvements.

• Ensure that all company safety rules and regulations are followed and promote general plant safety.

• Assist in internal/ external audits as needed.

• Other duties, as assigned

KNOWLEDGE AND EXPERIENCE

EDUCATION

Required:

Bachelor of Science degree

EXPERIENCE

Required:

5 years manufacturing experience with broad background in manufacturing processes

• 3years CAPA Process

• 2 years Quality manufacturing experience

• Proven history of product / process improvements utilizing Green/ Black Belt/Six Sigma techniques.

• Ability to generate validation protocols, which comply with the globalization standardization initiative.

• Experience working in medical device manufacturing industry

• Experience in metrology and gauge fixture design preferred.

• Experience working with high performing work teams desired

• Certificate in Quality Auditing

• 3years practical GMP / Medical Device manufacturing experience.

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…