Quality Engineer – Medical Devices

Job Summary

We are seeking a Quality Engineer with 3+ years of experience in the medical device industry to support quality assurance activities, ensure compliance with regulatory standards, and drive continuous improvement across manufacturing and quality processes.

Key Responsibilities
• Support Quality Management System (QMS) activities in compliance with ISO 13485, FDA 21 CFR Part 820, and GMP regulations.
• Conduct root cause investigations (CAPA, NCR, deviations) and implement corrective and preventive actions.
• Review and approve quality documentation, including SOPs, protocols, and reports.
• Participate in internal and external audits and support regulatory inspections.
• Collaborate with manufacturing, R&D, and regulatory teams to ensure product quality and compliance.
• Perform risk management activities (FMEA, risk assessments).
• Support process validation, equipment qualification, and product verification activities.
• Analyze quality metrics and drive continuous improvement initiatives.

Required Qualifications
• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 3+ years of Quality Engineering experience in the medical device industry.
• Knowledge of ISO 13485, FDA regulations, and GMP requirements.
• Experience with CAPA, NCR, root cause analysis, and risk management tools.
• Strong documentation, analytical, and problem-solving skills.

Preferred Skills
• Experience with process validation (IQ/OQ/PQ).
• Familiarity with statistical analysis and quality tools.
• Knowledge of design control and product lifecycle processes.