Post Market Quality Analyst 2 CR

Alajuela, Costa Rica

Costa Rica

• Education / Educación:

• 50% of total percentageof University Bachelor's degree in engineering, or related career.

• Experience / Experiencia:

• No experience required.

• Specialized Knowledge(Desirable) / Conocimiento especializado (preferible):

• FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947,EU MDD/MDR and any relatedISO and AAMI standards.

• Equipment qualification.

• Laboratory good practices.

• Test method and procedure development

• 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, Internet, Minitab, Oracle, Agile

• Summary of Duties and Responsibilities / Resumen de funciones y responsabilidades:

• Support Operational Excellence program and initiatives.

• Support local and extended CSPOs, VIP projects, improvement initiatives, NPIs, producttransfers, implementation of new technologies.

• Control best in class metrics and quality reports related to the implemented in the Post Market Surveillance Laboratory.

• Innovate processes to improve efficiency and ensure compliancewith the Post Market Surveillance’s requirements.

• Maintain, improve, and simplify procedures, processes, and methods.

• Support and promote the implementation of EHS programsto ensure peoplesafety and environment health.

• Coordinate services with suppliers and availability of the requiredsupplies in house.(as applicable).

• Coordinate and ensurethat required paymentsto vendors are performed on time.

• Ensure testing, investigations are performed in accordance with the procedures and on a timely manner.

• Support track and trending of complaints.

• Create and execute new procedures, new testing methods,validations and any other compliance requirements.

• Make decisions based on a risk thinking, implement tools as PFMEA,Fault Tree Analysis (FTA) and risk evaluation.

• Review and approvecomplaints investigations in the QMS, as required.

• Ensure equipment is properly calibrated and controlled with the QMS. Ensure Preventive Maintenance program is implemented as required.

• Provide guidance to CSPOs, inspectors, technicians, supervisors, and engineers in technical mattersrelated to Post Market Surveillance.

• Execute investigations such as OOTs, NCEs,CAPAs, IACAs and/or similar. Ensurethey are performed on time, in compliance with procedures and regulations.

• Escalate to the ClinicalSpecialists and PMS Manager in case there is any Potential AdverseEvent.

• Qualifications / Calificaciones:

• Drive for Results

• Planning

• Organizational Agility

• Listening

• Decision making

• Problem Solving

• Communication