About the role

AI summarised

The IPQA Assistant Engineer supports quality assurance by receiving and reviewing non-conformance reports, classifying their severity, initiating containment actions, and conducting root cause investigations using analytical tools like FMEA and 5 Whys. The role involves developing corrective and preventive actions, tracking their effectiveness, maintaining records in the QMS, and ensuring compliance with ISO 9001 and ISO 13485 standards. The engineer also analyzes NCR trends to recommend process or equipment improvements and works in a clean room and dry room environment.

ComponentsOnsiteENGINEERING

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, 5 why 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)