Post Market Quality Engineer 3 CR
Description:
Post Market Quality Engineer 3 CR
Alajuela, Costa Rica
+ **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)
+ **Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:**
+ Microsoft Office, Minitab, Oracle, Agile and H1.
+ **Qualifications / Calificaciones:**
+ Drive for Results
+ Planning
+ Organizational Agility
+ Listening
+ Decision making
+ Problem Solving
+ Communication
+ **Summary 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 like 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).
+ Acts as mentor to other Post Market Specialists; assists in new employee training.
+ Direct or perform the creation or update QMS documents.
+ Reviews and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws, and regulations.
+ Identify and recommend improvements to the organization, processes, procedures, and the Quality Management System
+ Directs or performs investigations.
+ Leads timely and insightful response to investigations.
+ Responsible for assigned department metrics and leads projects or initiatives to reach departmental goals.
+ Prepares agendas, leads meetings and creates and tracks action items.
+ Responsible for ensuring appropriate required information is documented in complaints. Partners with TS or Field Service.
+ Manages and performs quarterly Post Market Surveillance Review boards including, leading, assembling, and presenting to key stakeholders.
+ Responsible for managing the Investigation Records escalated from Review Boards and potential other sources such as Potential Adverse Reported Complaints.
+ Serves as a Focal point for assigned business unit regarding Data Requests for product complaints and analysis.
+ Reviews other customer communication (response letters, acknowledgement letters) as appropriate.
+ Identify and recommend improvements to the organization, processes, procedures, and the Quality Management System.
Same Posting Description for Internal and External Candidates