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Tier-1 brand, mid-level QA role, metro location, and 2+ years experience increase candidate competition.
Medical-device V&V and regulated standards create high domain specificity, limiting transferability.
Lab V&V skills, regulated documentation practices, and protocol execution requirements make shortlisting moderately strict.
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Own and execute verification and validation test plans and protocols for Immunoassay and Clinical Chemistry product lines, including hardware and software.
Maintain instruments and collaborate with global R&D teams to support system level verification and validation activities.
Identify, analyze and resolve system level defects through detailed root cause analysis following regulated documentation practices.
Bachelor’s or Master’s degree in Science, Engineering, or related field.
2+ years of relevant work experience.
Experience executing test protocols in a laboratory setting.
On-site work required at Bengaluru India Development Center.
Experience or familiarity with medical devices, biotech, or FDA regulated environments.
Knowledge of middleware communication protocols such as ASTM and HL7.
Understanding of medical device quality standards like IEC 62304, ISO 13485, and ISO 14971 or software testing certifications (e.g. ISTQB Foundation) likely to increase competitiveness.