Quality & clinical validation lead

The Quality Assurance & Clinical Validation Lead will be responsible for establishing and maintaining the Quality Management System (QMS) in compliance with ISO 13485, while simultaneously planning and executing clinical and design validation activities to demonstrate that medical devices meet intended use, user needs, and clinical performance requirements.
This role acts as a critical bridge between R&D, Clinical, Regulatory, and Manufacturing, ensuring that product development is compliant, clinically relevant, and audit-ready.
Key Responsibilities
Quality Assurance & QMS
- Establish, implement, and maintain an ISO 13485:2016 compliant QMS
- Develop, review, and control:
- Quality Manual
- SOPs, Work Instructions, and Forms
- DHF, DMR, and DHR
- Ensure effective implementation of design controls, including:
- Design inputs and outputs
- Design reviews
- Design verification and validation
- Manage Non-Conformances (NCs), deviations, CAPA, and change control
- Plan and conduct:
- Internal audits
- Supplier audits and qualification
- Management Review meetings
- Ensure inspection and release controls for incoming, in-process, and final products
- Maintain training records and competency matrices
- Support risk management activities as per ISO 14971
- Prepare and support ISO 13485 Stage 1 & Stage 2 audits and regulatory inspections
Clinical Validation & Clinical Research
- Plan, execute, and document clinical validation activities aligned with intended use and user needs
- Develop and manage:
- Clinical Validation Plans
- Validation Protocols and Reports
- Usability validation documentation
- Coordinate with surgeons, clinicians, and key opinion leaders (KOLs) for clinical input and evaluation
- Conduct and oversee:
- Simulated-use studies
- Usability and human factors validation
- Cadaveric / animal studies (if applicable)
- Collect, analyze, and document clinical performance and safety data
- Support preparation of:
- Clinical Evaluation Plans (CEP)
- Clinical Evaluation Reports (CER)
- Post-Market Clinical Follow-Up (PMCF) plans
- Ensure traceability between:
- User needs
- Clinical risks
- Validation evidence
- Feed clinical insights back into design improvement and risk mitigation
Cross-Functional & Regulatory Support
- Work closely with R&D to ensure design outputs are verifiable and clinically relevant
- Coordinate with Regulatory Affairs for submissions in India, EU, and other target markets
- Ensure alignment between clinical data, risk management, and quality documentation
- Support post-market surveillance and complaint trending from a clinical perspective
Required Qualifications
- Bachelor’s or Master’s degree in:
- Biomedical Engineering, Life Sciences, or related field
- OR
- Clinical background (MBBS / BDS / Allied Health Sciences) with medical device experience
- 3–7 years of experience in:
- Medical Device Quality Assurance and/or
- Clinical Validation / Clinical Research
- Hands-on experience with ISO 13485 and medical device documentation
Key Skills & Competencies
Strong understanding of:
- ISO 13485
- Design controls
- Clinical validation methodologies
- Risk management (ISO 14971)
- Excellent technical documentation and audit handling skills
- Ability to translate clinical feedback into quality and design improvements
- High attention to detail and regulatory discipline
- Comfortable working in a fast-paced startup environment
Why This Role Matters
This role is central to ensuring that:
- Products are safe, effective, and clinically validated
- The organization is audit-ready at all times
- Clinical insights directly strengthen design, usability, and regulatory success
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