Quality Team Lead

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.

• →Provide direction and coordination to quality associate and quality clerks relative to specific quality focus areas – Customer Claims, Shipping Audits, Quarantine and Non-Conforming Product (Holds, SIQ, Returns, Damage).
• →Assist Quality Supervisor and/or Manager in preparing procedures, work instructions, shipping papers and any other duties assigned to meet requirements.
• →Implement and monitor all procedures and processes as they relate to Customer Claims, Shipping Audits, Quarantine, Hold, Expired, Damages, Return Goods and Recalled product
• →Ensures the accurate and actionable audit, custom claims, product hold and quarantine processes and records for the making of decisions.
• →Ensure compliance to Document and Record Control procedures.
• →Responsible for assuring products are placard, stored and distributed in a manner that meets their product requirements and prevent unsaleable conditions prior to shipment to customers
• →Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements and continuous improvement.
• →Understand, track, and trend Quality department Key Performance Indicators.
• →Review operating goals and standards on a daily basis to monitor achievement.
• →Share best practices and tools to accelerate continual quality improvement into DC organization locally and across the region, initiating lessons learned and best practice concepts; to introduce pro-active improvement and prevent recurrence of issues.
• →Create and maintain documents in accordance with the Document Control Procedure, Work Instructions, Regulatory Compliance documentation, corrective action and other related forms and records.
• →Participate in internal/external quality audits and report findings.
• →Duties include creating monthly management reports, including internal and external reports.
• →Damage Subject Matter Expert, providing feedback to DC personnel on damage standards and training as needed.
• →Other duties as assigned

• A minimum of 5 years relevant experience in Quality, Supply Chain and/or Distribution Center operations, preferable in Medical Device and/or Pharmaceutical regulated industry
• Supervisory experience a plus
• Working knowledge and application of ISO 13485 and 21 CFR 820 preferred
• Computer skills (Excel, Word, Power Point, etc.)
• Minimum of 2 years Material Handling Equipment experience

• Excellent communication, problem solving, organizational and interpersonal skills are essential.
• Ability to understand FDA, EPA, DOT and OHSA rules and regulations
• Self-motivated and directed, requiring minimal supervision
• Demonstrated ability to work in teams to obtain results is required.
• Effective skills in analytical thinking and problem solving required

• High School diploma required
• Associate Degree preferred