About the role
Job Description
Job Summary:
The Quality Specialist supports development, implementation, and maintenance of the Regional Quality Management System. The individual in this role must work cross functionally both horizontally and vertically within the organization.
- Execute and maintain the North America Quality Management System (QMS), with primary ownership of document control and training programs.
- Lead development, implementation, and sustainment of QMS processes to ensure compliance with FDA 21 CFR 820, SOR/98-282, and ISO 13485 requirements.
- Serve as a key resource for CAPA investigations, root cause analysis, data analysis, and continuous improvement initiatives , driving effective corrective and preventive actions.
- Partner cross-functionally to train, guide, and support teams on QMS requirements, audit readiness, and continuous improvement practices.
- Actively contribute to CAPA reviews and Management Review meetings , providing insights and tracking progress of quality system performance.
- Support leadership in coordinating and executing quality-related projects and system enhancements.
- Build and maintain strong cross-functional relationships, enabling collaboration across all levels while leading or supporting end-to-end QMS activities and initiatives.
Required Qualifications:
- Bachelor of Arts (BA), Bachelor of Science (BS) in related field and/or 4-years related job experience.
- Some travel may be required
Knowledge and Skills:
- Strong conceptual knowledge of quality management systems and industry related regulations (FDA 21 CFR 820, ISO 13485, SOR/98-282).
- Strong interpersonal skills, including persuasion, effective communication, objectivity, assertiveness, and thoroughness.
- Ability to implement processes and systems.
- Ability to apply a systematic and analytical approach to problem solving.
- Ability to create and present material, adjusting to the level of the audience.
- Develop solutions to routine assigned activities of moderate scope & complexity.
- Ability to influence without authority coupled with ability to work collaboratively and effectively communicate with peers and management across all functions. May function in a project leadership role.
- Will interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.).
- Considered Functional Level Subject Matter Expert in assigned areas of Quality Systems.
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?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
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.