Quality Executive

Description

• Assist in the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements for medical devices.
• Support regional quality assurance activities, including document control, change control, non-conformance management, CAPA (Corrective and Preventive Actions) processes, and complaint handling.
• Participate in internal and external audits (e.g., regulatory inspections, third-party audits, supplier audits) by preparing necessary documentation, assisting auditors, and supporting follow-up actions.
• Manage adverse event reporting to regulatory authorities in SEA in accordance with local reporting requirements and timelines.
• Coordinate and support Field Safety Corrective Actions (FSCA), including field safety notices, communication to stakeholders, tracking, and closure.
• Support the evaluation of post‑market surveillance data and ensure appropriate escalation, trending, and reporting in line with global and regional quality procedures.
• Act as a liaison between SEA markets and global quality teams to ensure consistent and compliant post‑market quality processes.
• Support the review and approval of quality-related documents, including procedures, work instructions, and records, to ensure accuracy and compliance.
• Assist in conducting quality training programs for employees across the SEA region to ensure understanding and adherence to quality requirements.
• Contribute to the investigation of quality issues, root cause analysis, and the implementation of effective corrective and preventive actions.
• Support the monitoring and reporting of key quality metrics to identify trends and drive continuous improvement initiatives.
• Collaborate with cross-functional teams, including Regulatory Affairs, Operations, and Commercial, to ensure alignment on quality objectives and processes.
• Stay updated on relevant regulatory changes and industry standards impacting medical device quality and communicate these effectively within the organization.
• Perform other quality-related duties as assigned by the Quality Management.

Qualifications

• Bachelor's degree in a relevant scientific or engineering discipline (e.g., Biomedical Engineering, Biotechnology, Chemistry, Pharmacy).
• Minimum of 2-4 years of experience in a Quality Assurance or Quality Control role within the medical device, pharmaceutical, or other regulated industries.
• Familiarity with Quality Management Systems (QMS) requirements, particularly ISO 13485 and/or FDA 21 CFR Part 820.
• Basic understanding of regulatory requirements for medical devices in Southeast Asia countries (e.g., HSA, MDA, TFDA, etc.) is a plus.
• Experience in post‑market quality activities such as adverse event reporting, vigilance, or FSCA coordination is an advantage.
• Experience with document control, non-conformance, CAPA, and change control processes.
• Strong analytical and problem-solving skills with attention to detail.
• Excellent written and verbal communication skills in English.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Willingness to travel occasionally within the SEA region if required.