Quality Assurance & Regulatory Affairs Manager

We are looking for a QA Lead to drive and strengthen our Quality Management System (QMS) in compliance with ISO 13485. This is a hands-on role focused on execution and ownership of quality processes across the product lifecycle—from development to validation and post-market.

The role involves working closely with cross-functional teams (R&D, clinical, operations) to ensure consistent product quality, compliance, and audit readiness, with limited involvement in regulatory submissions.

• Bachelor’s or Master’s in Biomedical Engineering or related field
• 4–5 years of experience in Quality Assurance for medical devices (ISO 13485)

• Hands-on experience in implementation and maintenance of ISO 13485 QMS
• Strong experience in QMS documentation (SOPs, forms, records, change control)
• Experience in CAPA, deviation management, and root cause analysis
• Qualified or experienced internal auditor (ISO 13485)
• Familiarity with risk management (ISO 14971, FMEA)
• Understanding of design control processes (DHF, DMR, traceability)
• Working knowledge of standards such as:
• IEC 60601 series
• IEC 62304 (software lifecycle)
• IEC 62366 (usability engineering)
• Basic awareness of Indian MDR 2017, CE, and FDA requirements

• Maintain and continuously improve the Quality Management System (ISO 13485)
• Manage QMS documentation, including SOPs, templates, records, and change control
• Ensure document control and traceability across all projects

• Plan and conduct internal audits, track findings, and ensure closure
• Lead CAPA, deviation, and non-conformance investigations
• Drive root cause analysis and effectiveness checks
• Support external audits (ISO, CDSCO, CE/FDA) and ensure audit readiness

• Support and ensure design control compliance (DHF documentation, V&V records)
• Drive risk management activities (ISO 14971, FMEA) across products
• Ensure testing and validation activities meet quality and standard requirements

• Work closely with R&D and product teams to ensure quality is built into product development
• Ensure compliance with applicable standards
• Provide QMS and quality training to internal teams

• Act as a quality gatekeeper across projects and processes
• Drive a culture of quality and compliance across the organization
• Identify process gaps and implement continuous improvement initiatives

• Experience in handling ISO 13485 audits independently
• Exposure to Class B medical devices
• Experience working in a startup or fast-paced environment
• Familiarity with electronic QMS tools (preferred)

• Strong analytical and problem-solving skills
• High attention to detail
• Strong documentation and review skills
• Good communication and cross-functional collaboration
• Ability to take ownership and deliver results in a fast-paced environment