Senior Supervisor, Quality Control

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.

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 own capabilities and development.
• Focused on delivering results with 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 self and are impact focused.
• Consider the needs, challenges, and objectives of every person they interact with.
• Exhibit positive reinforcement to help others succeed.

Job Description

About the role

Works closely with and have impact on: Operations, Supply Chain

Reports to: Quality Manager, Hoya Medical (Suzhou) Co. Ltd. (HMSZ)

Role Overview

This position is responsible for the overall management of the QC laboratory operations and control of product quality inspections, environmental inspections and monitoring. This includes but is not limited to material incoming inspection product in-process and final inspection, environmental tests and monitoring. 

Duties and Responsibilities

- Responsible for incoming inspections, in-process and final product inspection and laboratory tests such as but not limited to product bioburden test, environmental monitoring, bacterial endotoxin test, product sterility, EO/ECH residue.

- Ensure test methods are established and validated for inspections and testing. Ensure test methods comply to applicable international standards and NMPA standards regulations.

- Manage OC team to ensure timely raw material and product release.

- Ensure robust investigations are performed for any OOS and deviation found from laboratories. Generate NC/CAPAs as necessary, perform data and root cause analysis, corrective and/or preventive actions.

- Establish environment awareness training program.

- Ensure Good Documentation Practices (GDP), Good Laboratory Practices (GLP), ALCOA and EHS requirements are implemented in laboratories.

- Collaborate with local and global teams to support the development of, and qualify new products and/or new processes.

- Support internal and external audits

- Perform other tasks as assigned by the manager

Requirements

Experience

• At least 5 years of working experience in the Medical Device Industry. (NMPA regulations, China Pharmacopoeia ChP)
• At least 5 years experience in Biological laboratory or biological testing field
• Familiar with ISO13485
• Working experience in product sterility, Endotoxin tests, EO/ECH tests
• Able to work / Worked in laboratory and cleanroom environment

Skills/Accreditations 

- Good Microsoft office and computer skills 

- Good command in English (reading, writing and speaking)

- Able to communicate well, has the people skills

- Good Analytical skills

Academic Qualifications 

• Degree in Medical Science, Pharmaceutical, Microbiology, Biology, or related field

Travel requirements 

- Minimal