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.
Responsibilities:- 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.
Primary Work LocationUSA NC - Four Oaks
Additional LocationsUSA CA - Redlands Distribution Ctr, USA GA - Covington Global Dist Center, USA IN - Plainfield
Work ShiftAt BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information$95,900.00 - $153,400.00 USD Annual
