Quality Assurance Microbiologist

About the role

Establishment Labs designs, develops and manufactures medical aesthetic devices and wellness solutions, with production at two MDSAP-certified, carbon-neutral, LEED Gold facilities in Costa Rica. The Quality Assurance Microbiologist investigates and provides microbiological guidance across product development, design transfer and manufacturing, acting as a technical resource who educates and supports cross-functional teams. The role also supervises the Microbiology Technician and promotes collaboration and continuous improvement.

Key responsibilities

• Support product development projects and design transfer efforts.
• Support the Regulatory Affairs department in registering and renewing product registrations.
• Coordinate with Engineering and Facilities the requalification of clean room systems such as HVAC and compressed air.
• Coordinate viable and nonviable monitoring of the clean room and products.
• Lead efforts to resolve nonconformities and out-of-specification results related to monitoring and potential sterilization risks.
• Communicate results to stakeholders and review third-party test and monitoring reports.
• Assess proposed changes to processes and products.
• Act as subject matter expert during internal and external audits and inspections.
• Lead, review or approve NCs, CAPAs, quality plans, intrusion plans and other quality system documents.

Required profile

• Bachelor's degree in Microbiology or Biotechnology Engineering.
• At least 2 years of experience in the medical device industry supporting laboratory testing.
• Advanced English (B2+ speaking and reading).
• Experience supervising one direct report; strong autonomy, time management and stakeholder management.

Required skills

• Bioburden testing and endotoxin testing.
• Environmental viable and nonviable monitoring.
• Strong analytical thinking, decision-making and prioritization.

The shift is Monday to Friday, 8:00 a.m. to 5:00 p.m., in a hybrid arrangement. Selection involves interviews with Talent Acquisition and the hiring manager, an English assessment and an assessment center evaluation.