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. 

As a Senior Quality Specialist at BD, you will be a key driver in ensuring the robustness and effectiveness of our Quality Management System. You will play a pivotal role in managing CAPA processes, conducting internal and external audits, integrating quality systems, and ensuring compliance with industry regulations.

 Key Responsibilities:

1. CAPA Management: Lead and oversee the Corrective and Preventive Action (CAPA) process, from identification and investigation to implementation and effectiveness monitoring. Ensure timely and effective resolution of quality issues.

2. Audit Coordination: Plan, conduct, and manage internal and external audits to evaluate the adherence to quality standards, regulations, and QMS procedures. Prepare audit reports, identify non-conformities, and guide corrective actions.

3. Quality System Integration: Collaborate with cross-functional teams to integrate quality management systems across various departments. Streamline processes, eliminate redundancies, and ensure consistency in quality practices.

4. Regulatory Compliance: Stay up-to-date with relevant industry regulations and standards. Ensure that the QMS remains in compliance and lead efforts to adapt to regulatory changes.

5. Documentation Control: Oversee the management of QMS documentation and records, ensuring accuracy, version control, and compliance with document control procedures.

6. Continuous Improvement: Lead and participate in continuous improvement initiatives related to QMS processes, procedures, and quality standards.

7. Training and Development: Provide training and mentorship to junior quality specialists, ensuring their growth and development within the organization.

Qualifications:

• Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Life Sciences).

• Minimum 7 years of experience in quality management with a focus on CAPA, audits, quality system integration, and regulatory compliance.

• Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g., FDA, ISO, GMP).

• Proficiency in CAPA software and auditing tools. (e.g. Trackwise)

• Demonstrated experience in leading and participating in internal and external audits.

• Excellent analytical, problem-solving, and communication skills.

• Certification in Quality Management (e.g., Certified Quality Auditor) is a significant advantage.

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, milita