QA/QC Engineer

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 environment
• 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.