About the role

AI summarised

This IPQA Assistant Engineer role is in quality assurance within electronics/medtech manufacturing. The position involves handling non-conformance reports, conducting root cause analysis using FMEA and 5 Why, implementing corrective actions, and ensuring ISO compliance in a cleanroom environment.

ComponentsFull-timeENGINEERING

Key Responsibilities

Receive and review non-conformance reports (NCRs).
Classify non-conformance by severity (critical, major, minor) and impact on product quality.
Initiate containment actions to prevent further defects, coordinate with production, maintenance, and quality teams to resolve issues promptly.
Conduct thorough investigations using tools such as Failure Mode and Effects Analysis (FMEA), failure mechanism, 5why and Fault Tree Analysis (FTA), 5 why analysis.
Document findings and validate root cause with cross-functional teams.
Develop corrective action plans to address immediate issues, implement preventive measures to avoid recurrence.
Track CAPA effectiveness through audits and performance metrics.
Maintain detailed records of NCRs, investigations, and resolutions in the Quality Management System (QMS).
Ensure compliance with ISO 9001 / ISO 13485, safety regulation, environment compliance.
Analyze NCR trends and identify systemic issues, recommend process or equipment improvement.

Requirements

Diploma in Mechatronic & Robotics/Electronics/Electrical Engineering.
Failure Analysis skill will be added advantage.
Strong interpersonal & analytical skills.
Self-motivated, independent, able to contribute as a team player.
Proficient in computer skills (Microsoft office, Excel, Words & Power point).
Comfortable to work in clean room environment+ dry room (0% humidity).