Job Description Summary

The Quality Specialist II is a senior-level role responsible for overseeing and enhancing quality systems, managing complex nonconforming product issues, and ensuring comprehensive compliance with regulatory standards. This role demands a proactive approach to maintaining and improving quality system performance, mentoring teams, and serving as a leading Subject Matter Expert (SME) in quality systems applicable to storage and distribution processes.

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. 

Job Responsibilities: 

• Own the evaluation and disposition of held or nonconforming products with a focus on minimizing Zero Escape incidents.
• Oversee intracompany claims and drive the resolution process.
• Conduct and handle QMS Audits, ensuring rigorous compliance and continuous improvement.
• Analyze metric data to identify trends and implement strategic quality improvements.
• Provide sophisticated operations support and maintain the DR License with utmost diligence.
• Act as the primary SME for ISO 13485, 21 CFR 820, and Corporate Policies/Procedures, ensuring strict adherence and application.
• Ensure the site’s compliance with local wholesale drug licenses as the designated representative.
• Mentor and train team members on QMS requirements and facilitate continuous process
• improvement initiatives.
• Maintain a high level of proficiency with SAP, WMS, and other ERP platforms, providing guidance and support.
• Assume responsibility for other positions during times of urgency, breaks, absences, or vacation to maintain operational continuity.
• Expected travel can be up to 25% of the time.

Education and Experience:

• Bachelor’s degree preferred.
• Associate degree, or a combination of equivalent education and experience, required in lieu of a bachelor’s degree.
• Minimum of 4 years of experience in a regulated environment, with a proven track record of quality system management.
• Advanced proficiency with SAP, WMS, and other ERP platforms is required.
• Experience with regulatory audits required.
• Exceptional technical writing skills and the ability to communicate sophisticated quality concepts clearly.
• Expertise in Microsoft Office Suite and advanced knowledge of ERP systems
• Industry-recognized certification in a Quality System Element or specialty (e.g., ASQ Certified Quality Auditor) is highly desirable.
• Experience as a designated representative preferred.

Knowledge and Skills:

Demonstrated leadership ability and experience in guiding teams to achieve quality objectives.

Strong analytical thinking and problem-solving skills with a proactive approach to addressing underperformance.

Physical Demands: 

The physical demands described are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions, in accordance with the Americans with Disabilities Act of 1990 and applicable state and local laws. While performing this job, the associate is regularly exposed to episodes of walking, standing, stooping, kneeling, hearing, long episodes of sitting, frequent use of hands and fingers, or typing which can include repetitive motion of the wrists, hands or fingers.

Work Environment: 
This position typically works in a normal office environment. The noise level in the work area is quiet to moderate. At times, position may be required to support operational activities in the distribution center.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are important 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.

Required Skills

Optional Skills

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Primary Work Location

USA NC - Four Oaks

Additional Locations

Work Shift

NA (United States of America)