Senior Executive - V&V (IVD Instrument)
Transasia Bio-Medicals Ltd. · Mumbai · onsite · Posted 2d ago
Undisclosed5–8 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Plan and execute verification and validation activities for IVD instruments as per defined protocols and product requirements.
- Perform functional, performance, and reliability testing of IVD instruments and their subsystems.
- Prepare and review verification and validation protocols, test reports, and technical documentation.
- Conduct testing of instrument accuracy, precision, reproducibility, linearity, and operational performance.
- Verify instrument hardware, software, and system functionality against defined specifications.
- Identify, investigate, and troubleshoot instrument failures, deviations, and performance-related issues.
- Coordinate with R&D, Design, Software, Quality Assurance, and Production teams for validation activities.
- Ensure compliance with applicable regulatory standards and guidelines, including ISO 13485 and relevant IEC standards.
- Maintain proper documentation of test results, risk assessments, change controls, and validation records.
- Support design verification, design validation, design transfer, and product improvement activities.
Sourced from naukri
Skills
Validation Testingverification and validationMedical device testing
About Transasia Bio-Medicals
Transasia Bio-Medicals Ltd.
Biotechnology
1.5k+
employees
1979
47 years old
Mumbai, Maharashtra
India
₹8.7L PA avg
Avg at Transasia Bio-Medicals
About
Erba is a global company focused on creating a social impact in the developing nations of the world by delivering innovative, affordable, and sustainable healthcare solutions
Industries
BiotechnologyIndustrial Machinery
Employee ratings
10 reviews
3.3/ 5
Culture
2.7
Career growth
2.2
Work-life
3.1
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