Quality Assurance Specialist at HOYA Vision Care

Hukou, , Taiwan -

Full Time

Start Date

Immediate

Expiry Date

29 Jul, 26

Salary

0.0

Posted On

30 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Management System, Customer Complaint Management, Root Cause Analysis, Inspection Standards, Instrument Calibration, CAPA, SOP Development, Data Analysis, Reporting, Optometry, Medical Device Regulations, Communication, Excel, Process Standardization, Operational Support

Industry

Medical Equipment Manufacturing

Description

MAJOR RESPONSIBILITIES 1. Regular quality control affairs: * Customer returned ST lens justification (sellable or not). * Customer RX returned lens justification (remake or not). * Internal defect justification (lens/frame damage). * Inbound inspection, for the special case to perform sampling or 100% check. 2. Customers complain management: * Collect, sort and analyze the customer complain cases. * Root cause finding & action owner identification. * Follow up improvement progress. 3. Quality standard & process standardization; to build/maintain the following: * Inspection standard. * Inspection instrument calibration planning and execution. * Product quality issue communication flow with suppliers (mainly HOLT). * Management of CAPA. * Establish the Quality Management System (QMS) including SOPs issuing and revision. 4. Reporting: (daily, weekly, monthly) * Product defect report. * C&M yield report. * Customers complain & action progress reports. * Regular/specific report requested by APAC/GQA. 5. Others shared jobs: * Operational support such as C&M outsourcing, defect lens registration and destruction. * Periodic reporting requested by regulation or industrial park. QUALIFICATIONS * Education: College degree, preferably in Optometry. * Experience: * 5+ years’ experience in medical device/pharma industry for quality assurance. * Keeps up-to-date knowledge and flexibility with medical devices, optical product, demonstrated ability to drive results. * Knowledge and Hard Skills: * Good communication, interpersonal, and consultative skills. * Keeps up-to-date knowledge and flexibility with solid execution, demonstrated ability to drive results. * English ability to read, write and understand. * Computer skills (Excel major) * Behavioral Attributes: * Initiative, proactiveness, and independence * Willingness to take challenge * Achieving Results HOYA Group: Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA’s divisions and business units research and develop products utilized in the healthcare and information technology fields. In the healthcare field, we provide medical device products such as eyeglasses, medical endoscopes, contact and intraocular lenses, orthopedic implants, surgical/therapeutic devices and medical device reprocessing and disinfection solutions. In the information technology field, we provide products such as optical lenses, photomasks and blanks used in the manufacturing process for semiconductor and LCD/OLED devices, text-to-speech, human resources and other software solutions and critical components for the mass memory and cloud storage industries. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people. HOYA Vision Care: As a global leader in optical technology, HOYA Vision Care is dedicated to providing innovative vision care solutions for every stage of a patient’s life. A steadfast partner to Eye Care Professionals around the world, it stands at the forefront of optical excellence. With a global presence, consisting of 43 laboratories and a growing team of 20,000 employees, HOYA Vision Care delivers innovative lenses and other vision care solutions to millions of people in 110 countries. We focus on a better tomorrow, today. You can become part of our story. HOYA Vision Care is the place where you can act according to your strengths and evolve according to your aspirations. It’s a place where you can shape the way you work, guided by our CLEAR Values, and empowered by generations of expertise. You can get involved in our sustainability initiatives and choose to become a One Vision ambassador. You can give back the gift of sight to people all over the world by deciding to work with us. We welcome people who challenge us to become better, who share our sense of purpose and who embrace growth so that our vision and mission align. We invite you to find out more, and together we can continue to provide vision for a lifetime. Driven by a passion for partnership as well as innovation, HOYA has been a partner to Eye Care Professionals for over 75 years, enabling them to give people the greatest gift, the gift of vision. We provide Eye Care Professionals with the lenses, consultation solutions and other services that help them to develop their practice while changing the way people see the world. We see them as visionaries, and everything we do is for them. Founded in Japan in 1941, today, HOYA has a presence in over 80 countries across the globe.

Responsibilities

The Quality Assurance Specialist is responsible for managing quality control processes, including customer returns, defect justifications, and inbound inspections. They also oversee the Quality Management System (QMS), handle customer complaints, and ensure compliance with inspection standards and reporting requirements.