Associate Engineer, Quality Operations (Medical Devices)

Location: Gelang Patah, Johor, Malaysia

Company

hirify.global develops the Omnipod wearable, waterproof medical device platform to support simpler and healthier lives for people with diabetes.

What you will do

• Manage lot qualification, in-process quality assurance, environmental monitoring, and microbiology testing.
• Support equipment validation, inspection procedure development, and testing system qualification.
• Investigate quality issues, deviations, nonconformances, CAPA, and field returns in the Master Control system.
• Track, trend, and analyze qualification data while providing feedback to Manufacturing, Quality, and Lifecycle Engineering.
• Optimize pre- and post-sterilization testing and improve investigation and quality system processes.
• Support product release activities, quality programs, training, documentation updates, and internal and external audits.

Requirements

• Bachelor’s degree, preferably in science or engineering.
• Fresh graduates or candidates with quality experience in the medical device industry are eligible.
• Fluent English and Malay are required.
• Working knowledge of ISO 13485 quality system standards.
• Ability to manage competing deliverables and collaborate effectively across organizational levels and functions.
• Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint.

Nice to have

• Microbiology testing experience.
• Auditor training certification for ISO 13485 or another industry quality management system standard.

Culture & Benefits

• Work in a performance-driven environment focused on customer expectations and shared values.
• Contribute to technology designed to be wearable, waterproof, and adaptable to users’ lifestyles.
• Collaborate with Manufacturing, Engineering, Marketing, Quality, and other company functions.