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
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