Quality Assurance Microbiologist

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.

About the Role:

The Quality Assurance Microbiologist is responsible for investigating and providing microbiological guidance across product development, design transfer, and manufacturing processes. This role serves as a key technical resource, educating and supporting cross-functional teams on microbiological topics. The position requires strong problem-solving skills to address complex and unfamiliar technical issues arising from regulatory inquiries, industry standards, or evolving regulations. Additionally, the Quality Assurance Microbiologist oversees and supervises the Microbiology Technician while promoting collaboration and continuous improvement within the organization.

Main responsibilities:

• Support product development projects and correspondent design transfer efforts.
• Support the Regulatory Affairs department in the registry and renewal of existing registrations of products.
• Coordinate along with the Engineering and Facilities department the requalification of critical systems that serve. the clean room, such as the HVAC and compressed air system.
• Coordinate the viable and nonviable monitoring of the clean room and product.
• Lead efforts to address nonconformities and out-of specification results related to viable and non-viable monitoring activities, and events that could compromise the sterilization of products.
• Communicate to stakeholders the result of the activities under his/her responsibility.
• Review reports about testing and monitoring activities executed by third parties.
• Perform assessments to proposed changes to the existing processes and products.
• Acts as subject matter expert in topics related to the area under his/her responsibility during internal and external audit and inspections.
• Lead, review or approve NCs, CAPAs, Quality Plans, Intrusion Plans, or any other Quality System document assigned by his/her direct supervisor.

Requirements:

• Bachelor’s degree in Microbiology or Biotechnology Engineering.
• Minimum 2 years of experience in medical device industry, supporting laboratory testing activities.
• Advanced English B2+ (speaking and reading).
• Knowledge and hands-on experience with microbiologist testing, including: Bioburden testing/endotoxins testing/environmental viable and non-viable monitoring.

 Soft skills:

• Strong autonomy and ability to work independently.
• Team management and leadership skills, with responsibility for supervising one direct report.
• Excellent time management and organizational skills.
• Strong analytical thinking, decision-making, and prioritization abilities.
• Effective negotiation and stakeholder management skills.
• Ability to work collaboratively with external suppliers and service providers.
• Strong financial acumen with experience managing budgets and controlling expenses

 Test to the process:

• Interview with Talent Acquisition
• English Assessment
• Assessment center Evaluation
• Competency-based interview with the Hiring Manager and Team

The shift for this position is Monday through Friday, from 8:00 a.m. to 5:00 p.m. (Hybrid role)

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.