Quality Assurance Specialist - Logistics

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:  Supply Chain and Logistics, Commercial Teams

Reports to: Senior Manager Quality Assurance EMEA

Function: Quality Assurance

Work Location/Site: Mörfelden

Role Overview

In this exiting role, you will be working very closely with our Logistics team in Mörfelden and act as ambassador to drive forward quality assurance strategies.

Duties and Responsibilities

• Assist in the ongoing compliance of activities performed at the EMEA warehouse in Mörfelden with relevant requirements and Hoya’s quality management system; supports implementation of improvements as necessary 
• Support quality oversight of logistics processes, including inbound, outbound, returns, supplementary labeling, etc. 
• Perform checks and disposition / release of incoming and returned goods in accordance with Hoya’s and MDR requirements
• Train Logistics employees on applicable regulations and quality system requirements to raise awareness about regulatory and quality compliance. 
• Support documentation and management of non-conformances, investigations, corrective and preventive actions (CAPAs) related to logistics.
• Support processing of product complaints for EMEA region, return of complaint samples, as well as customer communication regarding complaints.
• Support/performs other QA activities, as required

Requirements

Experience

• 2-3 years of experience working with quality systems in a regulated environment, preferably at least 2 years of experience in the field of medical device quality systems (acc.to ISO 13485, EU MDR, EU GDP)

Skills/Accreditations

• Strong communication skills with a strong attention to detail;
• Good sense of supply chain and distribution will be a plus; Good analytical skills; Comfortable in an international fast-paced and changing work environment. 
• Fluent in German (writing & speaking), and a good command of English is desirable. 
• Proficient at databases/ systems, Excel, and other Microsoft Office tools

Academic Qualifications

• Bachelor’s degree in the fields of technology, healthcare or Sciences OR equivalent combination of education and experience required

Travel requirements

• 5% - mainly EMEA wide on occasion