Koh John Email & Phone Number

Singapore, Singapore

Singapore

This role provides leadership oversight and management for Quality Assurance – Quality Management System across all Global Business Units for Singapore Operations. The primary focus is to define appropriate QMS standards / procedures and to assess appropriate compliance with them and, where necessary, to organize support in achieving compliance with all applicable local Asian and medical device regulations such ISO13485, FDA 21 CFR Part 820, EU Medical Devices Directive (EU MDD), Europe Medical Device Regulations (EU MDR), Good Distribution Practice for Medical Devices (GDPMDS) by HSA and manage external audit from certification body or regulatory agency.• Manage regional regulatory conformance activities; including support to change management and deviation impact assessments external audit, and CAPA notifications. • Develop, implement internal audits plan and audit schedule and lead a group of auditors, conduct internal audit to ensure the compliance to FDA 21 CFR Part 820 and ISO13485.• Manage operational efficiency with proactive oversight CAPA process, ensuring Site compliance.

Singapore

Singapore

Supporting design and development, maintain the quality systems ensuring compliance to existing and emerging quality system requirements internationally and ensure the new product development is compliance to establish system documents. Support corporate suppliers and others site quality system audit and leading in the continuous improvement of overall quality aspect related to product design and quality management system.Principal duties and ResponsibilitiesQuality System• Establish, implement and maintain quality system procedures and work instruction that aligned to company policy and international system requirements. (i.e. ISO 13484, CFR Part 820, HSA on GDPMDS, Malaysia GDPMD etc.)• Assigned as a lead auditor, conduct internal audit to ensure the compliance to establish quality system.• Ensure all internal and external feedback related to quality system are addressed.• Set-up and maintain quality system that compliance with the respective region regulations (Singapore - GDPMDS, Malaysia – GDPMD, Austria and China – CFDA).• Prepare and maintain the documentations for Customer or Regulatory regulator audit.• Conduct management review with top management to on the quality management update.• Prepare the Design and Development site for external audit (Notified Bodies and/or Regulatory Bodies). New Product Development• Ensure that all established procedures and instructions are being following• Provide expertise guidance to identify and reduce product risk.• Ensure verification and validation and reviews are conducted.• Compliance component qualification.• Conduct compliance audit on the new product development.• Conduct Risk management to ensure products compliance to the ISO 14971.• Conduct supplier audit or qualification and others site audit to ensure they compliance with regulation i.e. FDA Part 820, ISO 13485.