Posted:4 days ago|
Platform:
On-site
Full Time
Quality Assurance Engineer -
URL - www.optrascan.com
The QA Engineer will support and maintain the Quality Management System (QMS) in compliance with regulatory requirements (e.g., ISO 13485, IEC 62304, FDA 21 CFR Part 820). The role involves ensuring that all products, processes, and documentation meet OptraSCAN’s high standards for quality and regulatory compliance.
· Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable international quality standards.
· Support design control, risk management, validation, and verification processes for scanners and software.
· Maintain and improve the Quality Management System (QMS) across departments.
· Review and approve SOPs, DHRs, DHFs, CAPAs, NCRs, and change controls.
· Conduct internal audits and support external audits (e.g., customer, notified bodies, FDA).
· Collaborate with engineering, manufacturing, and regulatory teams to ensure product quality at every stage of the lifecycle.
· Support software validation and documentation of AI algorithms per FDA/CE/MDR requirements.
· Participate in supplier qualification and vendor audits.
· Monitor and report on key quality metrics (e.g., defect rates, complaints, CAPA status).
· Ensure traceability and document control throughout product development and release.lease.
· Bachelor’s degree in biomedical engineering, Quality, Life Sciences, or related field.
· 3–6 years’ experience in a medical device, diagnostics, or regulated health tech environment.
· Familiarity with digital pathology, AI in healthcare, imaging devices, or SaMD is a plus.
· Strong knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QSR, and EU MDR/IVDR regulations.
· Experience with QMS tools, document control systems, and audit practices.
· Excellent written and verbal communication skills.
· Detail-oriented,with strong problem-solving and cross-functional collaboration abilities.
OptraSCAN
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