Job Description
Quality Management Systems / Quality Assurance Manager
Department: Quality,Regulatory & Compliance
Location: Singapore
Reports to: Business Director
Employment Type: Full-time, Permanent
Job Level: Manager / Senior Manager
About AITbiotech
AITbiotech Pte Ltd is aSingapore-based molecular diagnostics and bioinformatics company dedicated to advancing clinical decision-making through innovative genomic and diagnostic technologies. Our product portfolio — including abONE, abSEQ, abNEX, abGenix X,and abTES — serves clinicians and healthcare institutions across SoutheastAsia. We are committed to the highest standards of quality, safety, and regulatory compliance as we scale our operations and expand into new markets.
Role Overview
The QMS/QA Manager will be responsible for maintaining and continuously improving AITbiotech's Quality Management System in alignment with ISO 13485, HSA (Singapore MDA) regulations, and CE-IVD/IVDR requirements. This is a dual-focus role: ensuring our QMS operates robustly across all product lines while actively leveraging AI-assisted tools to modernise quality processes, documentation workflows, and regulatory intelligence. The successful candidate will be a pragmatic quality professional who understands both the regulatory landscape for in vitro diagnostics and the emerging potential of AI to enhance quality operations.
Key Responsibilities
1. QMS Maintenance & Continuous Improvement
- Own and manage the end-to-end ISO 13485-certified QMS, including document control, change control, CAPA, internal audits, and management review processes.
- Conduct periodic QMS gap analyses, identify process weaknesses, and drive corrective and preventive action plans.
- Maintain and improve the Quality Manual, SOPs, work instructions, and related controlled documents across all departments.
- Lead internal audits and coordinate external/third-party audits; prepare audit responses and oversee closure of non-conformances.
- Foster a quality culture across the organization through training programmes and quality awareness initiatives.
2. Regulatory Affairs & Certifications
- Manage and maintain regulatory submissions and product registrations with HSA (Singapore MDA) for IVD medical devices.
- Lead CE-IVD/IVDR compliance activities, including technical documentation, Declaration of Conformity, and liaison with Notified Bodies.
- Monitor changes to applicable regulations (ISO 13485, IVDR, HSA MDA, ASEAN AMDD) and assess impact on existing QMS and product registrations.
- Coordinate with external regulatory consultants and legal counsel on cross-border market access strategies in Southeast Asia and beyond.
- Support product development teams with regulatory input during design and development, risk management (ISO14971), and design verification/validation activities.
- Manage post-market surveillance activities including complaint handling, vigilance reporting, and periodic safety update reports.
3. AI Integration in Quality Operations
- Identify and pilotAI-assisted tools for QMS functions including intelligent document management, automated non-conformance tracking, audit trail analysis, and regulatory intelligence monitoring.
- Collaborate with IT and bioinformatics teams to evaluate and deploy AI/ML solutions that improve quality data analysis, risk assessment, and complaint trending.
- Develop validation frameworks and procedures for AI tools used in quality-critical processes, ensuring compliance with applicable standards.
- Stay current with industry guidance on AI use in regulated medical device environments (e.g., FDA AI/ML guidance, IMDRF frameworks) and translate into internal policies.
- Champion responsible AI adoption within the quality function — balancing efficiency gains with regulatory traceability and auditability requirements.
4. Supplier & Partner Quality
- Qualify and periodically audit critical suppliers and contract manufacturers; manage approved supplier lists.
- Review and negotiate Quality Agreements with suppliers, distributors, and contract service providers.
- Manage OEM partner quality interfaces, ensuring incoming product quality and supply chain compliance.
5. Cross-functional Collaboration
- Partner with R&D, operations, sales, and commercial teams to embed quality requirements into new product introduction and product lifecycle management.
- Provide QA sign-off for batch releases, labelling reviews, and product changes.
- Represent the quality function at senior leadership level; produce quality KPI dashboards and trend reports.
Qualifications & Experience
Essential
- Bachelor's degree or higherin Life Sciences, Biomedical Engineering, Molecular Biology, or a relateddiscipline.
- Minimum 5 years of experiencein Quality Assurance/QMS roles within a regulated medical device or IVDenvironment.
- Demonstrated working knowledge of ISO 13485:2016 and hands-on experience maintaining or auditing a certified QMS.
- Practical experience with HSA (Singapore MDA) IVD product registration processes.
- Solid understanding of CE-IVD/IVDR requirements, technical file structure, and conformity assessment pathways.
- Proficiency in CAPA management, risk management (ISO 14971), and non-conformance investigation methodologies.
- Strong documentation skills with meticulous attention to detail.
- Excellent communicator with the ability to engage regulators, auditors, and internal stakeholders at all levels.
Preferred
- Postgraduate qualification in Regulatory Affairs, Quality Management, or equivalent.
- Certified Quality Auditor(CQA, IRCA, or equivalent) or ISO 13485 Lead Auditor certification.
- Experience in next-generationsequencing (NGS), molecular diagnostics, or genomics-based IVDs.
- Exposure to ASEAN regulatory frameworks (e.g., BFAD Philippines, NPRA Malaysia, TFDA Taiwan).
- Hands-on experience with AI/automation tools applied to quality or regulatory processes (e.g., AI-driven document review, intelligent CAPA platforms, regulatory intelligence software).
- Familiarity with electronic QMS (eQMS) platforms such as Veeva Vault QMS, Master Control, or Qualio.
- Experience in startup or scale-up environment with the ability to operate independently and build processes from limited infrastructure.
Core Competencies
- Regulatory Acumen — deep understanding of IVD regulatory frameworks and ability to translate requirements into actionable QMS controls.
- Analytical Thinking —data-driven approach to quality problem solving, root cause analysis, and trend identification.
- AI Curiosity &Adaptability — genuine interest in applying AI/ML tools to regulated quality environments, with a compliance-first mindset.
- Cross-functional Influence —ability to influence without authority across R&D, operations, and commercial teams.
- Ownership & Initiative —self-directed and proactive; comfortable operating in a fast-moving scale-up environment.
- Audit Readiness — confident representing the company during regulatory inspections and stakeholder briefings.
