Job Description Summary

We are seeking a highly motivated, collaborative, results-oriented and experienced Sr.Staff Quality Specialist to join our team and help us deliver innovative medical devices to patients around the world. As a Sr.Staff Quality Specialist, you will play a crucial role in managing, reporting, and monitoring internal audit nonconformances. This position involves overseeing audit records, executing relevant metrics and reports, and ensuring compliance with regulatory and quality standards. You will work closely with cross-functional teams to track audit commitments, develop audit responses and plans, identify and mitigate risks, and resolve challenges. The ideal candidate will have a proven track record in managing complex projects, with a strong understanding of project management principles, audits, regulations, and compliance

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. 

This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through March 31, 2026.

CAPA Management: 

1) Oversee the transition of audit findings from OneAudit system to the Corrective and Preventive Action (CAPA) in TrackWise. 

2) Collaborate with cross-functional stakeholders to ensure proper, timely, and accurate transitions. 

3) Maintain frequent communication on pertinent details of transitions with appropriate contacts. 

Audit Coordination: 

1) Manage internal audit observations. 

2) Collaborate with cross-functional teams to ensure adherence to regulatory requirements and internal policies. 

3) Identify appropriate owners for audit findings and monitor audit phase timeliness. 

4) Serve as a liaison between owners and internal auditors. 

5) Identify areas of non-compliance and work with relevant departments to develop corrective action plans. 

6) Perform administrative tasks within the audit system, where appropriate. 

Regulatory Compliance: 

1) Stay up to date with relevant industry regulations and standards. 

2) Ensure audit responses are complying and lead efforts to adapt to regulatory changes. 

3) Prepare compliance reports for senior management. 

Continuous Improvement: 

1) Lead and participate in continuous improvement initiatives related to monitoring the audit program and overseeing audit phase execution. 

  

Qualifications: 

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

• Minimum 11 years of experience in quality management with a focus on CAPA, audits, and regulatory compliance. 

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