QA Specialist (SN0394)

We are seeking a Quality Assurance (QA) Specialist to drive regulatory compliance and quality excellence in AI-driven medical devices.

• The ideal candidate will play a key role in navigating regulations, streamlining compliance processes, and fostering a culture of quality.
• This role requires expertise in ISO standards, QMS management, and software validation, along with a pragmatic, self-driven approach to continuous improvement.

Key Responsibilities

• Enable rapid and compliant product launches by guiding product teams through regulatory requirements for AI-driven medical devices.
• Develop and implement streamlined QMS processes that align with ISO 13485 and support efficient product development.
• Proactively identify and mitigate compliance risks, ensuring continuous process improvements.
• Manage key QMS processes, including document control, training, supplier management, Computer Software Validation (CSV), issue resolution (NCs and CAPAs), and change management.
• Oversee verification and validation (V&V) activities, ensuring proper documentation and compliance with ISO 14971 (risk management) and IEC 62304 (software development).
• Foster a quality-focused culture by collaborating with cross-functional teams to promote compliance and efficiency.
• Stay updated on evolving AI regulations and standards, integrating new compliance requirements into processes.

Key Requirements & Skills

• 3+ years of experience with ISO 13485 and QMS management.
• 2+ years of experience in QA/RA for software products, including ISO 14971 and IEC 62304.
• document control, training, supplier management, CSV, issue resolution
• Strong analytical and problem-solving skills
• Independent, self-motivated work style
• Excellent written and verbal communication skills in English.
• Experience with QA/RA in AI-enabled software.
• Knowledge of electronic QMS systems.
• Understanding of ISO/IEC 27001, ISMS, and GDPR requirements.

Hiring Team Member

Avula Srivalli

Recruitment Coordinator

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