Role Summary
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.
Qualification
- Bachelor's or Master's in Biomedical Engineering or related field
- 4–5 years of experience in Quality Assurance for medical devices (ISO 13485)
Experience & Skills
- 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
Roles & Responsibilities
QMS & Compliance
- 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
Audits & CAPA
- 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
Design Quality & Risk Management
- 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
Cross-functional Collaboration
- 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
Quality Culture & Ownership
- 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
Add-on / Preferred Skills
- 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)
Other Skills
- 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
