Sr. Manager Post Market Quality

We are the people who give possibilities purpose

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.
Job Description

The Sr. Manager, Post Market Quality, MMS is based in North America and reports to the Director, MMS Product Quality & Communications . The job holder is accountable for the end-to-end field action process for the MMS business unit, including,

• Timely execution of field actions within North America while aligning and coordinating with Regional PMQ Representatives from EMEA, LATAM and Greater Asia to ensure alignment of field action execution.
• Conducting timely Field Action Committee (FAC) meetings.
• Providing customer and regulator input into FAC decisions.
• Ensuring FAC decisions are consistent and align with regulator expectations.
• Ensuring field action documentation (customer letter, 806 report, GRIA, etc.) is created.
• Monitoring field action reconciliation and guiding the PMQ Field Action Operations organization to ensure appropriate effectiveness levels are achieved based on the Field Action Strategy.
• Ensuring alignment between field actions, CAPAs, complaint trends, and post-market surveillance activities to support sustainable risk reduction
• Driving global alignment on field action strategy, timelines, and execution expectations in partnership with regional PMQ representatives
• Use of metrics and data analytics to assess field action execution, effectiveness, and emerging post-market risks.
  
  • Coordination with regulatory bodies (FDA, etc.) as needed

• Audit Support for field actions and related decisions
• Continuous improvement projects as needed

Qualifications:

• BA/BS degree or equivalent in a Life Science, Engineering, Physical Science, Nursing with an advanced technical degree; MBA preferred
• Minimum of 10 years of experience in quality & regulatory management within an FDA/Competent Authority regulated environment.
• Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the medical device and / or in vitro diagnostics industries, e.g., 21 CFR Parts 7, 806, ISO 13485, 14971 etc.
• Strong preference for FDA Class II and Class III medical device and / or in vitro diagnostics experience, and prior BD experience is highly desirable.
• Excellent written and oral communication and organizational, project management skills.
• Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying principles of process excellence.
• As a change agent, motivated to improve organizations and not be satisfied with status quo.
• High level of problem identification, analysis, and formulation of conceptual / technical and business solutions
• Knowledge of product failure modes.
• Strong knowledge of influencing, coaching, and people development principles
• Expertise in conducting and participating in both internal and external audits.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.


We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.


To learn more about BD visit

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location
USA CA - San Diego Bldg A&B

Additional Locations
USA AZ - Nogales, USA AZ - Tempe Headquarters, USA CA - El Cajon, USA CA - San Diego (BDB), USA CA - San Diego (IDS), USA CA - San Diego - Otay Mesa, USA CA - San Diego - Road to the Cure, USA CA - San Diego TC Bldg C&D, USA CA - San Jose (Reagents), USA CA - San Jose - Montecito, USA CO - Golden, USA CO - Lakewood, USA CO - Louisville, USA DC - Washington, DC, USA MA - Andover, USA MA - Marlborough, USA TX - El Paso - Northwestern Dr., USA TX - El Paso - Plaza Circle

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information
$158,300.00 - $261,100.00 USD Annual