Job Description Summary

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:

• Serve as Quality Manager for all operations activities.

• Supervise the Quality Inspection, QC Shipping/Receiving and Calibration Departments.

• Supervise operations quality engineers.

• Coordinate inspection activities to insure product and process compliance to acceptance requirements.

• Control nonconforming product and coordinates final product acceptance/release activities.

• Oversee operations quality involvement in process validation activities.

• Develop, implement, and maintain quality systems to ensure FDA and ISO compliance.

• Assist and/or lead the migration of the BBI quality system from on BD division to another.

• Optimize quality systems to effectively identify, measure and reduce cost of quality activities.

• Identify, support, and develop departmental resources to achieve business and quality objectives.

• Actively participate in all facility audits (FDA, ISO, Corporate and Division).

• Participate in the development of process FMEAs.

• Review and approve all engineering changes for existing product, processes, and materials.

• Promote and support multi-discipline teamwork.

• Oversee establishment of manufacturing quality plans for transferring product designs to manufacturing.

• Maintain calibration system and associated activities.

• Manage the Material Review Board process.

• Support existing product/process improvement programs.

• Support new product development programs.

• Hire and develop Quality resources at BBI.

Required Qualifications:

• Process validation knowledge.

• Technical knowledge of measuring equipment and the required calibrations.

• Strong working knowledge of QSR, ISO 13485, MDR, ISO14971 (Risk Management), and Canadian Medical Device requirements.

• Experience conducting quality audits (internal and supplier).

• Experience managing and hosting external audits (e.g. FDA, ISO).

• Strong organizational skills.

• Strong working knowledge of statistical quality tools.

• Strong oral and written communication skills.

Preferred Qualifications:

• ASQ Certification (CQE, CRE, CQA, CQM) preferred.

Education and/or Experience:

• Bachelor's Degree

• Minimum of 5 years’ experience in federally regulated industry to include QA, compliance, and/or Regulatory Affairs.

• Minimum 5 years supervisory experience preferred.

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 in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

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.

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