Sr. Manager Post Market Quality
$158.3k - $261.1kBD
BD is one of the largest global medical technology companies in the world. We drive innovation by turning ideas into real solutions that improve health outcomes worldwide. Job Summary The Sr. Manager, Post Market Quality, MMS in North America is responsible for the complete field action process for the MMS business unit. The role reports to the Director, MMS Product Quality & Communications. Responsibilities Execute field actions within North America in a timely manner and coordinate with regional PMQ representatives from EMEA, LATAM and Greater Asia. Conduct timely Field Action Committee (FAC) meetings and provide customer and regulator input. Ensure FAC decisions align with regulator expectations and are consistently documented (customer letters, 806 reports, GRIA, etc.). Monitor field action reconciliation and guide the PMQ Field Action Operations organization to meet effectiveness goals based on the Field Action Strategy. Align field actions with CAPAs, complaint trends and post‑market surveillance activities to support risk reduction. Drive global alignment on field action strategy, timelines and execution expectations in partnership with regional PMQ representatives. Use metrics and data analytics to assess field action execution, effectiveness and emerging post‑market risks. Coordinate with regulatory bodies (FDA, etc.) as needed and provide audit support for field actions and related decisions. Lead continuous improvement projects as required. Qualifications BA/BS or equivalent in Life Science, Engineering, Physical Science, Nursing; advanced technical degree preferred. MBA is a plus. Minimum 10 years of experience in quality & regulatory management within an FDA or competent authority regulated environment. Comprehensive knowledge of worldwide regulatory standards (e.g., 21 CFR Parts 7, 806, ISO 13485, 14971). Preference for FDA Class II/III medical device or in vitro diagnostics experience. Strong written, oral communication and project management skills. Demonstrated ability to assess process effectiveness and lead improvement initiatives. Strong problem‑solving and analytical capabilities. Knowledge of product failure modes and influence, coaching and people development principles. Experience conducting internal and external audits. Benefits Salary range: $158,300.00 - $261,100.00 USD Annual. Equal Opportunity Statement 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, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics. #J-18808-Ljbffr BD
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