Risk Management and Compliance Engineer

HCLTech is hiring for Mechanical Design Engineers

Experience: Minimum of 6 months to Maximum of 2 years

Location: Chennai & Madurai

Interview Mode: Face to Face

Qualification: Mechanical/Biomedical Engineering (2024/2025)

Job Description:

Qualifications/ JD:

• Bachelor's degree in Mechanical / Biomedical, Quality Assurance, Regulatory Affairs, or a related field.
• Experience: 1 to 1.5 years of experience in validation within the medical device industry, with a focus on IQ, OQ, and PQ activities.
• Regulatory Knowledge: Strong understanding of medical device regulations, including FDA 21 CFR Part 820 and ISO 13485.
• Proven experience in medical device DHF / MDR assessment and remediation.
• Validation Expertise: In-depth knowledge of validation methodologies, including IQ, OQ, and PQ for equipment, utilities, and processes.
• Risk Management: Famili...