Assistant Engineer, Quality (Medical Devices)

Location: Pasir Gudang, Johor, Malaysia; onsite in office, laboratory, and manufacturing environments

Company

hirify.global develops products supported by structured manufacturing and quality processes.

What you will do

• Perform incoming, in-process, and final inspections and monitor product yield, defect trends, and quality KPIs.
• Investigate product nonconformities, customer complaints, returned products, and field issues, identifying root causes and corrective actions.
• Support validation activities, including IQ/OQ/PQ, test method validation, sampling plans, and Gage R&R.
• Maintain product quality records, document control, SOPs, work instructions, DHRs, and product release data.
• Support the implementation, maintenance, and continuous improvement of the QMS and participate in internal and external audits.
• Assist with supplier qualification, FAIR requests, supplier NCR and SCAR investigations, and corrective-action follow-up.

Requirements

• At least 1 year of experience in manufacturing quality, product quality, QMS, and/or supplier quality.
• Diploma or degree in engineering or a related technical field.
• Familiarity with ISO 13485, FDA QSR, and basic quality tools.
• Strong analytical, problem-solving, documentation, communication, organizational, and time-management skills.
• Ability to work in office, laboratory, and manufacturing environments, including extended standing, walking, color differentiation, and lifting up to 50 pounds.
• A valid international passport and driver’s license are required for international and local travel.

Culture & Benefits

• Cross-functional collaboration with engineering, production, and suppliers.
• Work across office, laboratory, and manufacturing settings.
• Exposure to audits, regulatory compliance, quality improvement, and supplier development.
• Daily use of computers and other digital devices.