Sr. Manager Post Market Quality
Remote, Multiple Locations
- ID de l'offre
- R-544144
- Category
- Quality
- Location
- Multiple Locations
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/BSdegreeorequivalentinaLifeScience,Engineering,PhysicalScience,Nursingwith an advanced technical degree; MBA preferred
Minimumof10yearsofexperienceinquality®ulatorymanagementwithinan FDA/Competent Authority regulated environment.
Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatorystandardsandlawsapplicabletothemedicaldeviceand/orinvitrodiagnostics industries, e.g., 21 CFR Parts 7, 806, ISO 13485, 14971 etc.
StrongpreferenceforFDAClassIIandClassIIImedicaldeviceand/orinvitrodiagnostics experience, and prior BD experience is highly desirable.
Excellentwrittenandoralcommunicationandorganizational,projectmanagementskills.
Abilitytocontinuouslyassesstheeffectivenessoffunctionalprocessesandtolead progressive improvement initiatives applying principles of process excellence.
Asachangeagent,motivatedtoimproveorganizationsandnotbesatisfiedwithstatus quo.
Highlevelofproblemidentification,analysis,andformulationofconceptual/technicaland business solutions
Knowledgeofproductfailuremodes.
Strongknowledgeofinfluencing,coaching,andpeopledevelopmentprinciples
Expertiseinconductingandparticipatinginbothinternalandexternalaudits.
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 https://bd.com/careers.
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&BAdditional 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 CircleWork 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
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