Job Description

• Manage internal lab facilities and coordinate with external test service providers

• Responsible for internal and external lab testing by establishing test protocols and reports

• Support daily operations and incidents arising from manufacturing and quality

• Collaborate with cross-functional teams and stakeholders to support product development and innovation

• Prepare technical documentation and SOPs

• Ensure compliance with relevant standards (e.g. ISO 13485, FDA and HSA)

• Support clinical trials and liaise with external research institutions and partners

• Drive R&D initiatives from bench research to pilot production and pre-clinical validation

• Explore new materials for medical applications and contribute to patent strategy

• Preferred knowledge of ocular anatomy and glaucoma condition & treatment

Requirements

• Degree in Science or Engineering with at least 3 years of related industry experience in clinical, medical devices or pharmaceutical space

• Knowledge with ISO13485, FDA, MDR, GMP and related medical devices quality standards

• Proven track record of implementing, integrating and refining QMS management and operations