Job Description Summary

The Quality Lead is accountable for Quality Control, maintenance and compliance to applicable Quality Systems. This position actively participates in quality guidance, product resolution decisions and statistical problem-solving techniques. The Quality Lead reports to the Quality Supervisor and/or Quality Manager.

Job Description

BE PART OF SOMETHING BIGGER!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Provide direction and coordination to quality associate and quality clerks relative to specific quality focus areas – Quarantine and Non-Conforming Product (Holds, Returns, Rebox, 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 Quarantine, Hold, Expired, Damages, Return Goods and Recalled product

· Ensures the accurate and actionable 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 reworked, labeled, 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

EXPERIENCE:

· A minimum of 5 years relevant experience in Quality, Supply Chain and/or Distribution Center operations, preferrable 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

COMPETENCIES:

· 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

EDUCATION:

· High School diploma required

· Associate Degree preferred

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

WHY JOIN US?

A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day. 

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates. 

TO LEARN MORE ABOUT BD VISIT HTTPS://JOBS.BD.COM/ (https://jobs.bd.com/

Primary Work Location

USA NC - Four Oaks

Additional Locations

Work Shift

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