Post-Market Surveillance Technician

at  Establishment Labs

REQUIREMENTS

• Engineering student, health sciences or related career.
• High School Diploma.
• Previous Quality or engineering experience (preferred).
• If not a career degree, at least Minimum 3+ years of experience in medical devices.
• Quality, Industrial, electronic or mechanical engineering student (preferred).
• Knowledge of ISO 9001, ISO 13485, FDA, CE Mark standards and GMP´s desired.
• Experience in the Quality Assurance of medical devices.
• Intermediate English and writing skills.
• Computer knowledge is required: spread sheets, word processor, other utilities, basic
• knowledge of commercial software package (i.e. Windows or similar) and basic computerconfiguration. Including statistical/data analysis and report writing skills.
• Ability to handle multiple tasks in a high volume environment where meeting customer deliverydates demands urgency.
• Demonstrate strong organizational skills and strong interpersonal skills in order to interact withthe customer, co-workers and manufacturing departments.
• Proven leadership and ability to drive teams.
• Solid communication and interpersonal skills.
• Highly developed soft skills.
• Ability to handle confidential information.
• Multitasking abilities.

• Supports the companies’ customer complaints system per the procedures and policies establishedby the Quality System and ensures it is appropriately implemented and compliant with applicableregulations.
• Recommends test, techniques and methods for the inspection of the materials, the calibrations ofthe equipment and the validations of equipment, product or processes.
• Support research, development and manufacturing engineering during new product start-ups andestablishes tools and method for testing new products and processes.
• Responsible for continual improvement activities to enhance the quality system.
• Investigates customers complaints on existing products.
• Root cause analysis and implementation of corrective action for process related concerns.
• Follow Quality performance indicators.
• Follow controls of the documentation related to the quality system.
• Ensures a system is in place to provide customers a timely respond related to product claims.
• Participate and collaborate with team members to achieve consistent processes while identifyingprocess improvements to drive efficiency and compliance.
• Coordinate and manage all activities to maintain the records of all laboratory testing.
• Conducts CAPA activities directed to address adverse trends identified as part of the PMS activities.
• Assures all actions required to optimize the quality, manage the risk, and maintain thecompliance of our products are planned and completed, and that the results drive quality andquality system actions.
• Other functions may be assigned as per business needs and management determination.