Quality Engineer

Job Title: Quality Engineer ( bio engineer or Mechanical)

Medical Devices Location: [Insert Location]

Job Type: Full-Time

Department: Quality Assurance

Reports To: Quality Manager / Director of Quality

Job Summary:

We are seeking a highly motivated and detail-oriented Quality Engineer with medical device industry experience to join our Quality Assurance team. The Quality Engineer will be responsible for ensuring compliance with regulatory requirements, supporting product development, maintaining quality systems, and driving continuous improvement initiatives in accordance with FDA, ISO 13485, and other applicable standards.

Key Responsibilities:

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, MDR, and other applicable regulations and standards.
• Lead or support CAPA (Corrective and Preventive Actions) investigations, root cause analysis, and implementation of effective solutions.
• Participate in risk management activities (e.g., FMEA) during product development and post-market phases.
• Review and approve validation/qualification protocols and reports (IQ/OQ/PQ) for processes, equipment, and software.
• Support internal and external audits (FDA, Notified Body, ISO, etc.); assist with audit preparation and responses to findings.
• Collaborate with R&D, manufacturing, and regulatory affairs to ensure quality requirements are met throughout the product lifecycle.
• Monitor and analyze product and process trends using statistical tools (SPC, DOE, etc.) to drive continuous improvement.
• Review and improve standard operating procedures (SOPs), work instructions, and quality documents.
• Manage nonconformance investigations, including root cause analysis, impact assessments, and corrective actions.
• Participate in supplier quality management, including audits, performance reviews, and incoming inspection plans.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related field (Mechanical, Biomedical, etc.)
• 0-2+ years of experience in a Quality Engineering role within the medical device industry
• In-depth knowledge of FDA QSR, ISO 13485, ISO 14971, and preferably EU MDR
• Experience with CAPA, risk management, validation, design control, and root cause analysis
• Proficient in quality tools and techniques (e.g., 5 Whys, Fishbone Diagram, FMEA, SPC, Minitab)
• Strong communication skills with ability to work cross-functionally
• CQE, CQA, or Six Sigma certification is a plus

Job Type: Permanent

Pay: ₹18,000.00 - ₹25,000.00 per month

Benefits:

• Health insurance
• Provident Fund

Work Location: In person