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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
- Accountable for our own capabilities and development,
- Focused on delivering results without excuses, and
- Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.
- We are looking for people who
- See beyond themselves and are impact-focused,
- Consider the needs, challenges, and objectives of every person with whom they interact, and
- Exhibit positive reinforcement to help others succeed.
**About the role**
**Works closely with and have impact on**:Global Research & Development (R&D), Post Market Surveillance, and Global Regulatory Affairs (RA) Teams
**Reports to**:Senior Manager QA R&D
**Function**:Global QA & Compliance Organization
**Work Location/Site**: Singapore / Global Headquarters
**Role Overview**
This position is responsible to ensure that products meet quality goals and regulatory requirements, including but not limited to FDA Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971 and maintain compliance of the Quality Management System (QMS).
**Duties and Responsibilities**
- Partner with R&D teams in the USA, Japan, and Singapore to ensure that design control is completed in accordance with procedures, WI, regulatory requirements, and assure that required outputs have been completed
- Execute risk management for devices, processes, and provide the assessment results from product development through to the launch
- Maintain and update risk management files with Global R&D/Manufacturing Engineering (ME) teams to support product development (Risk Management Plans, Risk Control Log, Benefit Risk Assessment Risk Management Report, xFMEA, etc.), and act as the Risk Management expert
- Assist in the review and approval of 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 (Compliance, rationale, objectiveness and statistics)
- Partner within Quality and R&D to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
- Review and approve biocompatibility protocols and reports
- Ensure compliance of IQ, OQ, tests method validation, Standard Operating procedures and work instructions regarding product development
- Maintain compliance to QMS procedures of the R&D Singapore site, and support the Singapore R&D Site - QA
- Support External audits by competent authorities and notified bodies
- Support internal audits at the local site, and other sites as required
- Review and approve other quality documents (e.g., IQ, OQ, PQ, WI, etc) within areas of responsibility
- Propose and execute quality/process improvements. Write/review policies/ processes/ procedures and related documents
- Manage and monitor the progress of the calibration and maintenance of testing equipment. Ensure calibration or maintenance records satisfy regulatory and QMS requirements (act as Equipment Control Administrator in Singapore)
- Participate in development projects and change control request meetings to support the resolution of engineering issues
- Collaborate with the post-market surveillance team and complaints investigation teams to maintain risk management process throughout a product’s lifecycle
- Provide support for other quality activities and improvement initiatives, quality data collection and trending, CAPAs, change controls, training, etc.
- Support initiatives as identified by management to support QMS and other regulatory requirements in Singapore
**Requirements**:
**Experience**
- At least 4+ years of Industry experience working as QE Engineer in Medical Device/ Pharmaceutical product or optical engineering business field
- Exp
