Senior Optical Quality Assurance Engineer

5 days ago


Singapore HOYA MEDICAL SINGAPORE PTE. LTD. Full time
About HOYA Surgical Optics

We are a leading Preloaded Intraocular Lens (IOL) company that provides innovative technologies and solutions to ophthalmic surgeons worldwide.

Our commitment to delivering high-quality results is grounded in a quality management system that continuously improves to meet changing global regulatory requirements.

We aim to create a conducive work environment for our employees and promote an inclusive culture based on our core values – Excellence, Passion, Innovation, Collaboration, and Accountability.

Job Overview

This position ensures that products meet quality goals and regulatory requirements, including FDA Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971.

The role involves partnering with R&D teams in the USA, Japan, and Singapore to ensure design control completion according to procedures, WI, regulatory requirements, and assuring required outputs have been completed.

Key Responsibilities
  • Execute risk management for devices, processes, and provide assessment results from product development through to launch.
  • Maintain and update risk management files with Global R&D/Manufacturing Engineering (ME) teams to support product development.
  • Assist in reviewing and approving design development plans, verification and validation protocols, reports, master V&V plans and reports, and design transfer.
  • Review and approve design verification test protocols, reports, and data from a logical point of view.
Requirements
  • At least 4+ years of industry experience working as QE Engineer in Medical Device/Pharmaceutical product or optical engineering business field.
  • Experience in test method validation, design control, design transfer, design and development process, and quality system.
  • Demonstrated knowledge of Risk Management (ISO14971), Design control, Design and Development Process, and Quality System.

We offer a competitive salary of SGD $120,000 - $150,000 per annum, depending on experience. Additionally, you will receive a comprehensive benefits package, including medical insurance, retirement plan, and paid time off.



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