Essential Duties and Responsibilities:
Quality Assurance:
- Lead the QA/RA team on the implementation and maintenance of QMS in accordance to ISO 13485:2016 requirements, and other applicable international standards/regulations.
- Identify gaps in QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements.
- Provide training to staff on QMS procedures and regulatory requirements.
- Oversee document control, ensuring that all quality documentation is accurate, up-to-date, and properly maintained.
- Plan and execute internal and external audit and risk management review accordingly.
- Participate and lead key investigations or issues to prevent recurrence. Responsible in ensuring product reliability through conducting of risk assessments.
- Evaluate and review product on time, implement and conduct investigations in order to formulate corrective actions. Regular reporting and following up to ensure timely closure of CAPA.
- Actively supporting product transfers and ensuring product qualifications and validations of software and processes are established.
Regulatory Affairs:
- Develop and execute regulatory strategies to obtain and maintain product approvals in multiple markets.
- Responsible in the preparation and submission of regulatory filings.
- Maintain regulatory compliance for all marketed products, including post-market surveillance and reporting.
- Monitor changes in regulatory requirements and communicate their impact to the organization.
- Liaise with regulatory authorities and notified bodies as necessary to ensure timely product approvals and renewals.
- Provide regulatory guidance to cross-functional teams, ensuring alignment with regulatory standards.
- Serve as Person Responsible for Regulatory Compliance (PRRC)
Work Experience Requirements:
- Minimum 5 years of relevant experience in QA/Tester for Application/software development in medical device industry.
- Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, and standards applicable to medical devices and software used for Medical Devices (IEC 62304, IEC 62366)
- Knowledge of applicable regulations for Medical Devices (e.g., 21 CFR 820, EU MDR 2017/745, US FDA 510K, HSA Health Products (Medical Device) Regulations, TGA)
- Hands-on experience in performance testing and functional testing for web application.
- Excellent communication skills to lead/guide the team.
- Strong QA background with experience in identifying details and accuracy in reviewing test plans, test cases and test reports.
Education Level Requirements:
· Bachelor’s Degree/Diploma in a relevant scientific or information technology discipline.
