Job Description Summary

The Sr. Manager Quality Systems and Customer Quality EMI (Electromechanical Instrumentation) reports to the Vice President of Quality EMI. This role is responsible for developing and maintaining quality assurance programs, policies and procedures for EMI. It will work across BUs and Central Quality to align process and procedures for the EMI site. This role will also focus on driving manufacturing quality issues to completion and developing dashboards for reporting out on overall EMI quality performance.

The Sr. Manager Quality Systems and Customer Quality will be responsible for ensuring the appropriate Quality agreements are in place as the EMI strategy is implemented. It will also be responsible for oversight of Quality BD Excellence initiative across the EMI sites and will be responsible of implementation of dashboards to track metrics and performance of the EMI sites. Quality System team members report directly to the Sr. Manager and are under their authority for performance reviews, career development, compensation, hiring, and termination. The Sr. Manager also partners with manufacturing, supply chain and procurement leaders, operating with independence to strengthen and improve EMI management and governance.

The role will have responsibility for providing leadership and support for Continuous Improvement programs through use of Six Sigma (Manufacturing, Transactional and Design for Six Sigma), Lean, Validation, CI tools and project management best practices.

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 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
The Senior Manager, EMI Quality Systems and Customer Quality will lead the quality team to implement quality systems in compliance with FDA regulations and internal policies/procedures; drive continuous improvement projects focused on product safety, quality and reliability; serve as the primary customer contact for quality related issues and ensure timely escalation of quality concerns; manage all aspects of complaint handling including the investigation of root cause and CAPA closure; collaborate with operations leadership to address complex quality challenges; oversee training programs for new hires and existing employees; develop metrics and reporting tools to monitor performance and progress against key quality indicators; and coordinate audits and regulatory inspections. This role will report directly to the Director, Global Quality Assurance and Regulatory Affairs.

Responsibilities

• Develops and implements effective methods of monitoring and controlling production processes to meet quality standards (e.g., Six Sigma, Lean)

• Collaborates with Operations management to establish quality goals and objectives

• Oversees development and implementation of corrective action plans to address non-conformances identified during audits or regulatory inspections

• Provides input into the design and validation of manufacturing equipment and processes

• Ensures adequacy of quality control procedures and frequency of testing

• Participates in the review and approval of product specifications and change controls

• Monitors adherence to Good Manufacturing Practices (GMP) and other applicable regulations

• Coordinates U.S. Food and Drug Administration (FDA) inspections and responds to agency observations

• Serves as the primary customer contact regarding quality issues and oversees the management of customer complaints

• Establishes quality assurance training requirements for production staff

• Collaborates with cross functional teams to investigate product defects and implement solutions to prevent recurrences

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Biotechnology, Business, or related field required

• Minimum 7 years relevant experience preferred

• Experience in medical device industry highly desirable

• Working knowledge of FDA regulations such as 21 CFR Part 820 and ISO 14971

• Lean / Six Sigm