Job Description Summary

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 ground-breaking 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. 

Position Overview

We're looking for a dynamic Customer Quality Manager to join our MDS-B2B team! In this pivotal role, you'll be the quality ambassador for our key accounts, building strong partnerships while ensuring our products meet the highest standards.

Reporting to the Sr. Manager for MDS-B2B, you'll lead all quality activities for your assigned accounts, becoming the trusted quality who navigates complex customer relationships with confidence and expertise.

Responsibilities:

Be the Customer Quality Champion

• Serve as the primary quality interface for your assigned customers across all their sites, including negotiation and approval of Quality Agreements and Customer Specifications. 
• Collaborate closely with Customer Quality Management teams and cross-functional BD colleagues to integrate quality and compliance initiatives while promoting business improvement for their customers.
• Represent the voice of customers within BD and be BD's quality ambassador to customers
• Engage confidently with senior management

Strategic Quality Agreement Management

• Understand customer needs across multiple products and sites
• Educate customers on BD's product specifics, manufacturing processes, and quality controls
• Negotiate Quality Agreements that align customer expectations with BD capabilities
  • Ensures alignment on descriptions of non-conformities/conditions, control methods, and AQL levels. 
• Ensure all specifications and agreements receive proper validation through BD's established processes
• Continuously supervise and update agreements to maintain alignment with evolving customer expectations

Organizational Change Leadership

• Evaluate Change Control submissions to determine customer impact
• Collaborate with project teams to prepare comprehensive documentation
• Craft clear Customer Notification of Change (CNC) letters and manage follow-up inquiries

Customer Advocacy & Communication

• Address quality and technical requests with precision and timeliness
• Conveys the customer’s needs and requirements within the BD organization.
• Contribute to measuring customer satisfaction and implementing enhancements
• Spark innovation to improve products, processes, and services that meet emerging needs

Complaint Resolution Excellence

• Serve as the central point for customer product/service complaints

• Gather comprehensive information for thorough investigations and transfers complaint to the Customer Complaints Coordinator for registration and assignation.

• Coordinate cross-functional investigations internally and with suppliers and develop resolution strategies
• Create detailed investigation reports and guide batch disposition decisions
• Follows-up with the customer on batch disposition, including submission/opening of RMA (Return Material Authorization), when applicable.
• Partner with BD functions to ensure timely complaint resolution and CAPA closure

Audit Facilitation Mastery

• Coordinate customer audit requests and agendas with finesse
• Ensure proper confidentiality agreements are in place
• Prepare site teams with critical customer insights and audit focus areas
• Accompany customers during for-cause audits to ensure expectations are met
• Support sites with post-audit communications and CAPA management

Required Qualifications:

• B.S. degree in engineering or related scientific field.

• 8 years of experience in pharmaceutical or medical device industries or other relevant industry.

Preferred Qualifications:

• M.S. degree in engineering or related scientific field.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong knowledge of Medical Device or Pharma