Engineer, Quality Lab

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: Senior Quality Control Supervisor, Hoya Medical (Suzhou) Co. Ltd. (HMSZ)

Role Overview

This position is responsible for the incoming, in-process inspections, finished inspections, environmental monitoring, as well as test method validations.

Duties and Responsibilities

- Perform incoming inspection and laboratory tests such as but not limited to product bioburden tests, environmental monitoring, bacterial endotoxin tests, product sterility, EO/ECH residue, and tabulate data concerning materials, products, or process quality and reliability.

- Implement OOS/OOT investigation if necessary and take action as required.

- Validate test method and establish SOPs/Work instructions/Forms for QC laboratory for recording, evaluating, and reporting quality data.

- Generate NC/CAPAs as necessary, perform data and root cause analysis, and corrective and/or preventive actions.

- Maintain and ensure Good Documentation Practice (DP) and ALCOA.

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

- Support internal and external audits

- Ensure applicable EHS requirements are strictly followed

- Perform the other laboratory duties as assigned by te manage

Requirements

Experience

• At least 3 years of working experience in the Medical Device Industry. (NMA regulations, China Pharmacopoeia ChP). 
• Familiar with ISO13485.
• Working experience in product sterility, Endotoxin Test, EO/ECH tests.
• Have worked in/Able to work in laboratory and cleanroom environments.

Skills/Accreditations 

- Good in Microsoft Office and Computer skills

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

- Good communication and people skills

- Good analytical skills

Academic Qualifications 

• Degree in Medical Science, Pharmaceutical, Microbiology, Biology, or related fields.

Travel requirements 

- Minimal