Senior Quality Engineer

Senior Quality Engineer – Medical Devices

Duration: Long-Term Contract

Experience

Required:

5–6 Years

We are actively seeking a Quality Engineer with hands‑on experience in the Medical Device industry to support quality engineering activities across the product development and manufacturing lifecycle. The ideal candidate will have a strong understanding of medical device regulations, quality systems, design controls, risk management, and validation while collaborating with cross‑functional teams to ensure product quality and regulatory compliance.

• Support quality engineering activities throughout the medical device product lifecycle.
• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971 requirements.
• Participate in Design Control activities including Design Reviews, Design History Files (DHF), and Design Transfer.
• Lead or support CAPA, Non‑Conformance (NCR), Root Cause Analysis, and Corrective Actions
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• Perform risk management activities including FMEA and risk assessments.
• Support Verification & Validation (V&V), process validation, and equipment qualification activities.
• Collaborate with R&D, Manufacturing, Regulatory Affairs, Supplier Quality, and Operations teams.
• Participate in internal/external audits and ensure compliance with quality management system requirements.
• Review engineering changes, specifications, protocols, reports, and technical documentation.