Sr. Engineer- Design Quality

Artech L.L.C. · Kerala, India

Role Overview:

ExP-5+ years

• Senior Design Quality Engineer (L3) for medical devices

• Ensures QMS compliance, design control, and regulatory adherence

• Supports product development and design-to-manufacturing transfer

Key Responsibilities:

• Support design changes and new product development

• Review and approve technical documentation, DHF, and risk files

• Ensure data integrity and audit DHF records

• Create risk management documentation

• Analyze post-market and risk data

• Participate in design verification/validation reviews

Additional Details:

• The candidate will join our R&D Division - location: Trivandrum, Puliyarakonam, working 5 days a week

• Interview process: 2 rounds - L1 virtual, L2 face-to-face with our R&D head

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