Post Market Surveillance Technician
at Establishment Labs
PDA, Provincia Alajuela, Costa Rica -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 24 Apr, 2025 | Not Specified | 25 Jan, 2025 | 2 year(s) or above | Health Sciences,Medical Devices,It,Citizenship,Iso,Interpersonal Skills,Writing,Teams | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
ABOUT US:
Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical aesthetic device technologies and wellness solutions. It is currently the world’s fastest-growing women’s health company.
Our Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica and are approved for sale in more than 85 countries.
Since 2018 the company trades on the NASDAQ stock exchange under the ticker symbol ESTA and has a market cap of around $1.8 billion.
This is an exciting opportunity to join an innovative international company in hyper-growth as we launch a significant revolution to transform the women´s aesthetics industry.
JOB REQUIREMENTS:
- Engineering student, health sciences or related STEM career.
- Previous Quality or engineering experience (preferred).
- If not a career degree, at least Minimum 2 years of experience in medical devices.
- 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, basicknowledge of commercial software package (i.e. Windows or similar) and basic computer configuration. Including statistical/data analysis and report writing skills.
- Ability to handle multiple tasks in a high volume environment where meeting customer delivery dates demands urgency.
- Demonstrate strong organizational skills and strong interpersonal skills in order to interact with the customer, co-workers and manufacturing departments.
- Proven leadership and ability to drive teams.
- Solid communication and interpersonal skills.
- Ability to handle confidential information.
- Oriented to results.
Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list of all responsibilities, skills or functions.
At Establishment Labs we’re committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace
Responsibilities:
- Supports the companies’ customer complaints system per the procedures and policies established by the Quality System and ensures it is appropriately implemented and compliant with applicable regulations.
- Recommends test, techniques and methods for the inspection of the materials, the calibrations of the equipment and the validations of equipment, product or processes.
- Support research, development and manufacturing engineering during new product start-ups and establishes 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 identifying process 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 the compliance of our products are planned and completed, and that the results drive quality and quality system actions.
- Other functions may be assigned as per business needs and management determinatio
REQUIREMENT SUMMARY
Min:2.0Max:7.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Clinical Pharmacy
Graduate
Medical devices
Proficient
1
Provincia de Alajuela, Costa Rica