Quality Specialist

About Bdx

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 Summary

Responsible for ensuring that all raw materials and products batch records are reviewed and released in a timely manner and in compliance with all Quality requirements. Assist in Calibration, Environmental Monitoring Reviews and Preventive Maintenance Administrator. The Quality Specialist will support the Quality Systems such as: Audits, CAPA and Management Review. The Quality Specialist will serve as QC Inspector Back-up.

Key Responsibilities

• Performs independent review of textile raw materials and subassemblies including yarns, fabrics, and tubular fabrics for conformance to specifications, including calculation of results using formulas and Excel spreadsheets.
• Ensures that all product lots meet the established in-process procedures, specifications and inspections, before his/her approval to release.
• Ensures that completed lot history records submitted for lot release review are secured prior to disposition.
• Responsible for timely completion of final product shipping authorization documentation.
• Maintain and file the lot history records and release activities documentation.
• Conducts Data and documentation review and analysis.
• Maintains receiving inspection, work in process and finished product DHR records, procedures, and specifications.
• Review lot history folders for final lot release sign off and files them in the appropriate location.
• Review a database with all yarn and chemical re-test dates required by the specification.
• Assist in writing inspection and test procedures and other documents relevant to incoming/receiving inspection, work in process, finished product and Lot Release.
• Assists in-house calibrations.
• Maintains calibration log and coordinate calibration of the respective gauges and equipment.
• Assist in the environmental monitoring reviews.
• Support the Quality Systems such as: Audits, CAPA and preparation of the Management Review deck.
• Perform and maintain SCAR’s and MRN’s.
• Assist Quality Manager/Quality Engineer as needed.