Executive - Quality Assurance, QMS

OVERVIEW

• The incumbent is responsible to assist Manager in the establishment, monitoring, maintenance, and continuous improvement of Hartalega’s Quality Management System (QMS) to ensure that the system is adequate, effective, and in compliance with customer, regulatory, and standard requirements.

DUTIES AND RESPONSIBILITIES

• Conduct internal quality audits as per the Internal Quality Audit Procedure and Plan, covering all elements in the EN ISO 13485: 2016, MDSAP (Medical Device Single Audit Program), ISO 9001: 2015, Medical Device Directives (MDD 93/42/EEC), Medical Device Regulations (MDR 2017/745), and any other applicable standards or regulatory requirements.
• Support Manager in facilitating and attending to customer/ external / third party certification body audits.
• Conduct un-scheduled/ ad-hoc audits where required to identify gaps or deficiencies in the quality system for continual improvement.
• Issue Corrective Action (CAR) or Preventive Action (PAR) for any nonconformities or potential nonconformities identified during the internal / external / third party certification body audits. Ensure that the Corrective Action Preventive Action Procedure is being adhered to and all actions taken are being followed-up and verified for its mimplementation and effectiveness within set timeframe.
• Ensure compliance of quality system documentation and records in accordance with the applicable standards and regulatory requirements.
• Oversee document control system in ensuring quality system documentation is prevented from damage and loss, and are always kept up to date, well maintained, and easily accessible and retrievable.
• Ensure QMS / Audit related procedures are being reviewed and updated in a timely manner.
• Manage deviations and standard change processes and ensure actions required to manage and comply with the changes are being followed-up and completed.
• Conduct awareness training on quality management system.
• Perform periodic analysis, trending, and reporting of audit results and CAPA performance.
• Assist Manager in driving improvement of the quality management system through continual improvement projects identified.
• Escalate unresolved issues to Manager / Assistant Manager for further action, whilst keeping process owner informed.
• Any other tasks / project assigned by superior and management

REQUIREMENTS

• Bachelor’s Degree in Science or Engineering field.
• Minimum 3 years of working experience in auditing and experienced in medical devices manufacturing environment.
• Strong hands-on knowledge in ISO 13485: 2016 and ISO 9001: 2015 standard requirements.
• Good communication skills in both verbal and writing, including listening skills (both English and Bahasa Malaysia)
• Sound knowledge in data analysis, and auditing skills.
• A good team player and have a good leadership.
• Ability to work in tight deadline, plan, organize and detail oriented.