Sr. Manager Post Market Quality

Becton Dickinson Medical Devices•San Diego, CA

6d•Onsite

About The Position

The Sr. Manager, Post Market Quality, MMS is accountable for the end-to-end field action process for the MMS business unit. This includes timely execution of field actions within North America, aligning and coordinating with Regional PMQ Representatives from EMEA, LATAM, and Greater Asia to ensure alignment of field action execution. The role involves conducting timely Field Action Committee (FAC) meetings, providing customer and regulator input into FAC decisions, and ensuring FAC decisions are consistent and align with regulator expectations. The job holder will ensure field action documentation (customer letter, 806 report, GRIA, etc.) is created, monitor field action reconciliation, and guide the PMQ Field Action Operations organization to achieve appropriate effectiveness levels based on the Field Action Strategy. This position also ensures 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, and using metrics and data analytics to assess field action execution, effectiveness, and emerging post-market risks are key responsibilities. Coordination with regulatory bodies (FDA, etc.) as needed, audit support for field actions and related decisions, and continuous improvement projects are also part of the role.

Requirements

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.

Responsibilities

Accountable for the end-to-end field action process for the MMS business unit.
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.