Sr Quality Systems Specialist-Labeling

We are the people who give possibilities purpose

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.

Job Description

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)

• Maintain labeling program
• Maintain/revise current labeling files utilizing Nice Label software.
• Assure label changes follow applicable regulations
• Assure labeling modifications are compatible with manufacturing operations
• Approve / reject labels according to regulatory requirements
• Coordinate labeling implementation with external and internal stakeholders
• Approve / reject supplier proofs
• Coordinate/ Support Raw Material Specification (RMS) revisions

Support document
Approve / reject RMS revisions as applicable
Coordinate training sessions to present RMS changes

• Coordinate the First Article process for labeling material.
• Coordinate Manufacturing Instruction revisions and training associated with labeling changes.
• Coordinate barcode creations or changes, as needed.
• Maintain Art Change Forms and Change Control as necessary.
• Must understand labeling and packaging FDA requirements via 21 CFR.

Education and Experience:

• Bachelor's Degree required
• Five years of experience in a medical manufacturing environment

Knowledge and Skills:

• Experience in FDA GMP and ISO requirements
• Experience in Nice Label and Adobe InDesign
• Understand Documentation systems in a medical manufacturing environment
• COMPUTER SKILLS:
• Basic Commercial software, MS-Word, Acrobat Suite
• OTHER SKILLS:
• Must be a team player.
• Must have excellent communication skills.
• Proficiency in English grammar

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 visithttps://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 TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift