Post Market Quality Engineer 2 CR
- Alajuela
- Permanente
- Tiempo completo
- Education / Educación:
- University Bachelor's degree in Engineering or similar.
- Experience / Experiencia:
- Minimum 2 years of professional experience, with a bachelor's degree, in positions of a similar nature.
- Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):
- FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947, EU MDD/MDR and any related ISO and AAMI standards.
- 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, Internet, Minitab, Oracle, Agile
- Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:
- Investigate returned products (complaints related).
- Facilitate, process, assess and close complaints in the Electronic Complaint Management System.
- Identify and escalate potential adverse events.
- Support and analyze best in class metrics and quality reports related to the implemented in the Post Market Surveillance Laboratory.
- Maintain, improve, and simplify procedures, processes, and methods.
- Innovate processes to improve efficiency and ensure compliance with the Post Market Surveillance's requirements.
- Work with Technical Service and/or Field Service to ensure appropriate required information is documented in complaint.
- Work on problems of moderate in scope where analysis of situation or data requires a review of a variety of factors.
- Work on transfer of information for new products to the rest of the PMS team (if applicable).
- Participate in Internal and External Audits/Inspection and Assessments, as needed.
- Support risk assessments and Health Hazard Evaluation (HHE) processes.
- Execute and/or supervise execution of investigations such as OOTs, NCEs, CAPAs, IACAs and/or similar. Ensure they are performed on time and in compliance with procedures and regulations.
- Make decisions based on a risk thinking, PFMEA, Fault Tree Analysis (FTA) and risk evaluation.
- Support other facilities and OEMs/CMs, as required.
- Support local and extended core teams, VIP projects, improvement initiatives, NPIs, product transfers, implementation of new technologies.
- Implementation of cost reduction projects that support business strategies.
- Operational Excellence program and related initiatives.
- Support and promote the implementation of EHS programs to ensure people safety and environment health.
- Act as back up of the Complaints Laboratory Supervisor when requested by the Post Market Surveillance Manager.
- Qualifications / Cualificaciones:
- Drive for Results
- Planning
- Organizational Agility
- Listening
- Decision making
- Problem Solving
- Communication