About HOYA Surgical Optics (HSO)
HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.
HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.
At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.
HSO way of working
In fulfilling our roles, we are
We are looking for people who
Job Description
About the role
Works closely with and have impact on: Global R&D team, Post market surveillance and Regulatory Affairs
Reports to: Senior Manager QA R&D HSOU, Global QA & Compliance
Role Overview
The primary function of this position is to manage the Design Assurance activities for assigned projects in QA R&D Portfolio. This position collaborates with global cross functional team to achieve quarterly, midterm, and annual objectives and works under minimal supervision.
The Senior Engineer, Design Assurance QA R&D is also responsible for ensuring that products meet quality goals and regulatory requirements, including but not limited to FDA Regulations, ISO 13485, EU MDR requirements, MDSAP requirements, Usability Engineering per IEC-62366-1 and Risk Management per ISO 14971.
Duties and Responsibilities
Requirements
Experience
Skills/Accreditations
Academic Qualifications
Travel requirements
By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.
If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.
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