QA Expert Complaints and Vigilance

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

Job Title:QA Expert Complaints and Vigilance

Works closely with and have impact on: 

•         French Commercial Team

•         Global QA organization

•         Medical Advisors

Reports to: Senior Manager Quality Assurance

Function: Global Quality & Compliance

Work Location/Site: France / HSOE

Role Overview

This position supports QA and the French Commercial organization as the primary manager of French complaints and vigilance reporting in France.

Duties and Responsibilities

• Process complaints and vigilance reports in accordance with HSO procedures/requirements, as well as French & EU regulatory requirements.
• Be main point of contact in France for surgeons/hospitals /clinics and their representatives (i.e. pharmacists) for HSO complaints.
• Investigate complaints and gather complementary information from surgeon/pharmacist to complete complaint declarations
• Optimize process for collecting/returning complaint samples to HSO
• In case of product mishandling or unexpected issues, meet with surgeons to better understand issues, conduct investigation and to educate to avoid repeat problems.
• Be main point of contact for materiovigilance with French authorities such as ASNM 

Experience

• Complaints handling and vigilance reporting
• Compliance and regulations in French Medical Device market
• Experience in ophthalmology is a plus
• Solid experience working with quality systems

Skills/Accreditations

• Knowledge of refractive, IOL, cataract and optical surgical procedures is a plus

• Solid knowledge of French regulatory and compliance environment for medical devices

• Excellent communication and collaboration skills with both internal and external partners.

• Good understanding of quality processes and frameworks.

• Work with great attention to detail.

• Fluent French and excellent English language skills. Must be able to complete and submit documentation in both languages

Academic Qualifications 

• Degree in Optics/Optometry preferred; or equivalent technical training combined with relevant work experience

Travel requirements 

• Occasional travel to investigation sites and for meetings with Sales Team