Kerja Sepenuh Masa, Quality System Manager di Hoya Vision Care - Maukerja

About HOYA Group and HOYA Vision Care

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, orthopaedic 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: For over 80 years, HOYA Vision Care has been a passionate global leader in optical technology innovation. As a manufacturer of high quality, high performing eyeglass lenses, HOYA continues to drive optical technology innovation with the aim of finding the best vision care solutions for Eye Care Professionals. The company supplies lenses in over 50 countries with a network of over 22,000 employees and over 45 laboratories around the globe.

Role Overview

The Quality System Manager is responsible for developing, implementing, and maintaining the Quality Management System across HOYA Vision Care (HVC) entities and improve the level of regulatory compliance across the company.

This position also supports the global inspection readiness program and the global ISO13485 certification and creates effective oversight of HVC entities’ QMS performance (e.g.CAPA).

Duties and Responsibilities

• Lead the Global Quality System development to ensure compliance with the FDA Quality Management System Regulation (QMSR), ISO13485, MDR, and other regulatory/quality requirements
• Oversee and ensure compliance of quality system elements such as but not limited to, documentation, trainings, CAPAs, management review, internal audits, etc., with regulatory requirements and quality standards
• Establish, implement, and maintain the Quality Management System across HVC entities and ensure compliance at local sites.
• Define the QMS structure in the organization
• Define requirements for QMS documents across the organization
• Drive the standardization of practices across the company through the Quality Management System in collaboration with the Quality Heads of manufacturing sites, Rx labs, regions, and entities.
• Own the e-QMS platform (super admin role) and support e-QMS implementation at sites globally.
• Develop and maintain a training platform and associated content on quality and compliance; oversee compliance with the training program in cooperation with the HR department.
• Support management of CAPA (including reviewing and approval) as requried, preparing CAPA approval checklists.
• Gather data required for the preparation of the Global Executive Management Review
• Lead and support quality improvement projects/initiatives
• Drive continual and preventive improvement of quality management systems to support the conformity of process and product quality.
• Participate in Internal (Site and Global) HVC audits as requried.
• Coordinate the Global Internal audit program, coordinate Hoya Corporation audits, and external audits at the sites, and provide support for external audits as requried.
• Collect, organize, and analyze quality and other indicators related to the compliance of products, processes, and report on the conclusions and recommended actions through management review meetings.
• Establish and manage the Global CAPA Review Board.
• Perform other tasks at management discretion as required.
• Has the authority to make decisions within the scope of responsibilities outlined in this JD .
• Able to work in an international environment (different time zones).

Requirements

Experience

• At least 5 years of experience in managing Quality Assurance or Quality Systems in a highly regulated industry (Medical Device or Pharma). Medical device experience will be preferred
• Experience in managing external audits of Notified Bodies, and preferably FDA
• Must have monitored product quality in production or in the field
• Familiar with QMSR 21 CFR 820 regulations, ISO 13485, and MDR requirements. KGMP and NMPA regulations are a plus
• ISO 13485 certified lead auditor with experience in establishing and leading an Internal audit program.

Skills/Accreditations

• Quality orientation, continuous improvement, technical and professional knowledge and skills in Quality Assurance, Quality System Management, and Compliance
• Core leadership skills: adaptability, coach and develop others, drive execution, result orientation, authenticity,
• Collaborate, make decisions, resolve conflict, and influence
• Staffing skills; strong influencing skills
• Project management skills (both written and oral)
• Excellent communication and presentation skills
• Able to lead and motivate cross-functional teams
• AI and computer skills
• Proficient in Microsoft Office, Excel spreadsheets, process mapping, flowcharting, and database systems
• Knowledge of Power BI is a plus
• Proficient in English.

Academic Qualifications

• Degree in Engineering, Quality, or equivalent technical experience
• Formal education in Quality Management preferred
• ISO 13485 lead auditor certification
• Auditor certification by IRCA is a plus

Travel requirements

• Up to 20%, mainly to Thailand, Japan, Europe, and the USA