Quality Engineer

Job Summary

Responsibilities

• Review customer complaints and associated service data to determine risk levels and identify problem/cause codes.
• Conduct complaint investigations and perform detailed root cause analysis.
• Analyze data from quality systems including Complaints, Field Corrective Actions (FCA), FDA MDRs, and other quality inputs to identify trends and systemic issues.
• Prepare investigation summaries, reports, and recommendations based on analysis.
• Review existing investigation reports and identify GMP compliance gaps.
• Support development and implementation of corrective and preventive actions (CAPA).
• Drive continuous improvement initiatives and process control activities.
• Conduct data analysis using statistical and quality tools.
• Support maintenance activities for existing product lines and quality systems.
• Collaborate cross-functionally to improve product quality and compliance standards.

Requirements

• Bachelor's Degree in Engineering (B.E./B.Tech or equivalent).
• 13 years of experience in the Medical Device industry.
• Knowledge of FDA Quality System Regulations (21 CFR 820) and cGMP requirements.
• Experience in complaint handling, investigations, and root cause analysis.
• Familiarity with CAPA processes and quality systems.
• Strong analytical and problem-solving skills.
• Experience with statistical tools/software such as Minitab is a plus.
• Ability to read and interpret technical drawings and engineering documentation.
• Proficiency in MS Office tools (Excel, Word, PowerPoint) and databases.
• Ability to manage multiple tasks and projects effectively.

Preferred Experience

• Experience with ANSI/ISO/ASQC standards.
• Exposure to continuous improvement methodologies and process controls.
• Knowledge of medical device regulatory environments and compliance practices.