Role Overview
The QA/RA Specialist will play a pivotal role in ensuring the company's Quality Management System (QMS) remains compliant, effective, and aligned with international standards and regulatory requirements. This position bridges quality assurance and regulatory affairs, supporting product development, supplier management, and compliance activities across the organization.
Core Responsibilities
- Act as the designated Management Representative, overseeing the performance and suitability of the QMS in line with ISO 13485:2016 and relevant regulatory frameworks.
- Drive organizational awareness of evolving IVD medical device regulations and standards, ensuring timely adoption and compliance.
- Administer document, change, and record control systems, including management of externally sourced documentation.
- Conduct supplier evaluations and maintain the Approved Supplier List (ASL) to ensure ongoing vendor compliance.
- Lead the internal audit program, ensuring audits are executed according to schedule and findings are addressed.
- Manage the equipment calibration program, ensuring all monitoring and measuring devices are properly inducted, calibrated, and tracked.
- Contribute to design control, risk management, and software development processes throughout the medical device lifecycle.
- Support risk assessment activities (e.g., FMEA, SHA) and implement risk mitigation strategies across design, usage, and manufacturing.
- Participate in validation efforts for test methods, production processes, and software systems integral to quality and compliance.
- Assist in the investigation and resolution of non-conforming product issues, including corrective and preventive actions.
- Collaborate on the preparation of regulatory submissions for product commercialization.
Candidate Profile
- Bachelor's degree in a scientific discipline (Chemistry, Biochemistry, Microbiology) or Biomedical Engineering.
- At least 3 years of hands-on experience with ISO 13485 QMS in the medical device sector IVD background preferred.
- Proven involvement in product design, development, and risk management within the medical device industry.
- Strong communication skills with proficiency in English and Mandarin to support cross-functional collaboration.
- Demonstrated ability in analytical thinking, organization, and time management.
Interested applicants, please send your resume to [Confidential Information]
Jocelyn Lim (R1107183)
EA License No.: 12C5221
