Company Description:

Frisch Medical Devices Private Limited is an Indian manufacturer specializing in cardiovascular products.
The company offers CE-certified solutions, including drug-eluting stents, drug-eluting balloons(DEB/DCB),
PTCA balloons, and a variety of interventional accessories. Frisch Medical Devices is committed to developing high-quality medical devices that meet global standards. The company serves the healthcare industry with a focus on innovation and precision in cardiovascular care.

Role Description
This is a full time, On-site role for a Microbiologist.

Responsibilities :
1. Microbiological Testing & Analysis
· Perform bioburden testing, sterility testing, and endotoxin testing on medical devices and components
· Identify and characterize microorganisms using standard microbiological techniques
· Trend and analyse microbiological data to ensure product safety

2. Sterilization & Contamination Control
· Support sterilization processes (e.g., ethylene oxide, gamma irradiation, steam)




· Conduct sterilization validation and revalidation studies
· Investigate sterility failures and contamination events Develop and maintain contamination control strategies

3. Environmental Monitoring
· Design and execute environmental monitoring programs for cleanrooms and controlled areas
· Monitor air, surfaces, water, and personnel for microbial contamination
· Evaluate results and recommend corrective actions when limits are exceeded

4. Quality & Regulatory Compliance
· Ensure compliance with ISO 13485,
· Prepare and review microbiology-related SOPs, protocols, and reports
· Support regulatory audits and inspections

Qualifications:
Bachelor’s degree (B.Sc.) in Microbiology, Biotechnology, or a closely related life science field.
Master’s degree (M.Sc. or M.Tech) in Microbiology or Biotechnology

Experience: 2-4 years
[Experience in Medical Devices (ISO 13485) is an added advantage]

📌 Microbiologist (Vapi)
🏢 Frisch Medical Devices Private
📍 Vapi