Job Description Summary

This position is responsible for working as part of the Quality team at the Mebane NC Production facility. Activities will include but are not limited to: managing the change control process, processing change documentation, trouble-shooting issues that occur during change processing, maintaining and updating the change management procedures, and providing feedback on change documentation content.

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:

• SME (Subject Matter Expert) for the Change Control process.

• SME for the SAP ECR/ECO process.

• Responsible for delivering training to SAP ECR/ECO process.

• Responsible for the document control room and record management, including storage and archiving

• Responsible for ensuring change process procedures are current and being followed.

• Manage the change control and document change processes including feedback to authors and communication of timeliness.

• Responsible for updating Production document control books.

• Manages and maintains the signature control records.

• Provides support during audits.

• Updates/revises documents as needed.

• Ability to interpret Corporate, Unit and Department procedures.

• Mebane site representative at Change Control unit governance board.

• Completes additional responsibilities as assigned by Quality Management.

• Monitor task lists (e.g. aging change controls, supplier qualifications, etc.)

• Serve as alternate department learning administrator (DLA) for the site

Education and experience:

• Minimum of a bachelor’s degree with 2 years relevant experience or a combination of equivalent education and experience.

• Experience in a Quality Assurance or Quality Systems role within a regulated industry (preferably Medical Device).

• Experience with document control / change control methodologies.

Knowledge and skills:

• Basic knowledge of medical device regulations, industry or international standards.  FDA 21CFR820 and ISO 13485 preferred.

• Basic knowledge of Medical Device document change control practices, regulations, and standards.

• Excellent communication skills (verbal, written, and presentation). 

• Understands how to present information dependent upon the level of the audience.

• Ability to effectively manage time and manage priorities to meet deadlines.

• Ability to handle multiple task assignments. 

• Ability to interpret Corporate, Unit and Department Procedures.

• Ability to work with moderate supervision.

• Ability to work in a team.

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?

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 - Mebane

Additional Locations

Work Shift

US BD 1st Shift 730am-4pm (United States of America)