Job Description

The Sr. Post Market Quality Specialist performs statistical analysis of complaint and post market data for assigned Hologic product families, identifying trends, emerging signals, and opportunities for quality improvement. The Specialist owns and leads the Post Market Surveillance Review Boards (PMS RBs), presenting product performance metrics, trend summaries, and identified signals requiring follow up.

Working in close partnership with Product Quality Engineers (PQEs), the Specialist supports moderate complaint investigations by providing high quality data analysis, code review, and early signal assessment to inform cross functional decisions. The role maintains and reconciles PMS datasets, contributes complaint data for required PMS documentation, and serves as the primary point of contact for complaint related analytics.

• Education / Educación:

• University Bachelor's degree in Engineering or similar.

• Experience / Experiencia:

• 5 years on position of similar responsibility, decision making and problems resolution.

• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):
• FDA regulations, ISO 13485, ISO 14971, EU MDR and any related ISO and AAMI standards.

• Statistics.

• Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):
• Spanish/English (Advanced level)

• Qualifications / Calificaciones:
• Drive for Results
• Planning
• Organizational Agility
• Listening
• Decision making
• Problem Solving
• Communication

• of Duties and Responsibilities / Resumen de funciones y responsabilidades:
• Act as responsible of the PMS department during absence of the PMS Manager.
• Prepare and present Post Market Surveillance Review Board meetings for the products under her/his responsibility.
• Responsible for planning PMS Review Board meeting cadence.
• Ensure PMS RB records are released in the PLM system on a timely manner.
• Facilitator on moderate to complex investigations and conduct timely and insightful response to investigations. Work on problems of moderate to major in scope where analysis of situation or data requires a review of a variety of factors.
• Perform queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
• Identify unacceptable trends and ensure application of suitable corrective actions to reduce defects / meet quality objectives (when required).
• Facilitate investigations for emerging issues.
• Complete Post Market Surveillance documentation such as PMS Plans, PMS Reports, Periodic Safety Update Reports (PSURs), Canadian Summary Reports and similar documentation.
• Responsible for planning PMS Reports, PSUR and Canadian Summary Reports cadence.
• Provide complaint data for clinical documents such as Post Market Clinical Follow up (PMCF) and Clinical Evaluation documents.
• Develop and Maintain data mining tools to monitor trends. Define Control and / or Action Limits to detect emerging field issues.
• Participate in product transfers.
• Support Health Risk Assessments (HRA) and Health Hazard Evaluation (HHE) processes.
• Lead and facilitate cross functional meetings, as needed.
• Provide guidance to the PMS Team on the investigation process of her/his products.
• Implementation of cost reduction projects that support business strategies.
• Maintain, improve, and simplify procedures, processes, and methods.
• Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance requirements.
• Participate in Internal and External Audits/Inspection and Assessments.
• Make decisions following a risk-based approach, implement tools such as FMEA, Fault Tree Analysis (FTA) and risk evaluation.
• Supervise personnel and execute activities as One on one meetings, open sessions, recognition based on results, positive confrontation, open door policy, effective listening, assertive communication, among others, to foster an adequate work environment (as applicable).