Quality Assurance

1 week ago

Najafgarh, Delhi, India Madhu Instruments Pvt Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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 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 Readiness

  • Prepare DHF and Technical Documentation for Notified Body audits, FDA inspections, and internal audits.
  • Address findings related to EU MDR compliance (clinical evaluation, PMS data, UDI traceability) and FDA observations.

Risk Management & Post-Market Surveillance

  • Collaborate with Risk Management to ensure files reflect EU MDR Annex I (GSPR) and Annex III (PMS requirements).
  • Support updates to risk management files and PMS reports post-market launch.

Qualifications

Education:

  • Bachelor's degree in pharmacy (B. Pharma) or Biomedical Sciences or Diploma in Regulatory Affairs or M. Tech in Medical Devices

Experience:

  • 3+ years in QA/RA within the medical device industry
  • Hands-on experience with DHF/Technical Documentation under FDA 21 CFR 820 and EU MDR 2017/745
  • Familiarity with Annex II/III requirements, clinical evaluation reports (CERs), PMS, and clinical evidence

Skills:

  • Strong understanding of EU MDR Articles 10, 61, 83 and GSPR checklist implementation
  • Expertise in cross-functional project management and timeline tracking

Preferred Attributes

  • Certification in Regulatory Affairs (RAC) or Quality Auditing (CQA).
  • Experience with UDI requirements under EU MDR and FDA.
  • Knowledge of the EUDAMED database and technical documentation submissions.

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