Company Overview
Madhu Instruments Pvt. Ltd. is a leader in precision medical device manufacturing, committed to innovation, quality, and global regulatory compliance. With state-of-the-art facilities and a customer-centric approach, we develop and deliver cutting-edge diagnostic and therapeutic products that improve patient outcomes worldwide.
Senior Executive – Quality Assurance (Design File Compliance)
Department: Quality Assurance
Reports To: QA Manager
Collaborates With: R&D; | Regulatory Affairs | Manufacturing | Senior Leadership
Location: Delhi
Objective
Ensure the compliant compilation, documentation, and maintenance of Design History Files (DHF), Design Files, and Technical Documentation for medical devices. Adhere to ISO 13485:2016, FDA 21 CFR Part 820, and EU MDR 2017/745, guiding cross-functional teams to meet regulatory timelines and audit readiness.
Key Responsibilities
Design File Compliance
Develop and maintain DHF/Design Files and Technical Documentation per:
ISO 13485:2016 (Clause 7.3 – Design & Development)
FDA 21 CFR 820.30 (Design Controls)




EU MDR 2017/745 (Articles 10, 61, 83; Annexes II & III)
Include device description, intended purpose, specifications, GSPR checklist, risk management (ISO 14971), verification/validation protocols, clinical evaluation reports, and PMS plans.
Ensure full traceability between design inputs, outputs, risk controls, and regulatory requirements.
Cross-Functional Coordination
Liaise with R&D;, Regulatory Affairs, Manufacturing, and Clinical teams to gather and consolidate inputs.
Align documentation with EU MDR Annex III (PMS Technical Documentation) and track actions for CE marking and FDA 510(k) submissions.
Timeline Management & Reporting
Develop and monitor project timelines, integrating EU MDR milestones (e.g., PMS updates, CER revisions).
Provide regular (weekly/monthly) updates on progress, compliance gaps, and risks to the QA Manager, R&D; Manager, and Managing Director.
Regulatory Audit & Inspection Readines

📌 Quality Assurance (India)
🏢 Madhu Instruments
📍 India