Job highlights

- 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 setting

- Experience with QMS tools,document control systems,and audit practices

Key Responsibilities

- 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.

Qualifications:

- 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.

📌 QA/QC Engineer (Pune)
🏢 OptraSCAN
📍 Pune