QA Specialist (Biomedical)

Location: Singapore
Department: Commercial
Reporting To: Business Director
Works Closely With: Technology& Product Director, R&D Team, Sales Team
Employment Type: Full-Time

About Us

AITbiotech is a Singapore-based molecular diagnostics company focused on developing and commercialising innovative IVD solutions for infectious disease, oncology, and antimicrobial resistance. Our product portfolio — including the abTES qPCR assay range, abNEX next-generation sequencing panels, abSEQ genetic sequencer, and abONE integrated diagnostic system — is CE IVDR-certified and designed for clinical laboratories across diverse healthcare settings.
We distribute across Southeast Asia, South Asia, the Middle East, Africa, and Europe through a growing network of regional partners, with ambitions to expand significantly over the coming years.
We are a lean, high-trust team that moves fast and gives people real ownership. If you want to build something that matters in global diagnostics, this is the right place.

We are seeking a meticulous, highly organized, and proactive QA Specialist to join our team. In this multi-faceted, mid-level role, you will split your focus between operational quality assurance and design documentation (70%) and Quality Management System (QMS) maintenance (30%). A core focus of this role will be partnering with R&D to author, review, and compile technical files, design dossiers, and registration documentation required to launch new IVD products under SG HSA and EU IVD (CE-IVDR) frameworks.

Key Responsibilities

Operational QA, New Product Documentation& Design Control (70%):

• New Product Design Documentation: Collaborate closely with the R&D and engineering teams to establish, author, and maintain Design History Files (DHF), Device Master Records (DMR), and risk management files for new IVD products.
• Technical File Compilation: Create and compile comprehensive Technical Documentation Files (TDF) and Common Submission Dossier Templates (CSDT) required for regulatory registrations (CE-IVDR and HSA).
• Document Control Gatekeeping: Direct the end-to-end lifecycle of all quality documentation (SOPs, Work Instructions, and Quality Manuals), ensuring absolute adherence to Good Documentation Practices (GDP).
• Verification& Validation Support: Review and approve product validation/verification protocols and reports (IQ/OQ/PQ) for new laboratory assays and instruments.
• Batch Review & Release: Review manufacturing, lab, and packaging batch records to ensure full compliance before final product release.
• CAPA& Deviations: Coordinate non-conformance, deviation, and Corrective and Preventive Action (CAPA) systems. Lead root-cause analyses and track actions to closure.

QMS Maintenance & Compliance (30%):

• QMS Infrastructure: Maintain, update, and continuously improve the company’s Quality Management System framework in strict accordance with ISO 13485standards.
• Audit Orchestration: Plan, schedule, and execute internal quality audits across different departments.
• External Audit Support: Act as a key coordinator and technical document provider during external inspections by Notified Bodies (for CE-IVDR) and the Health Sciences Authority (HSA).
• Management Review: Collate, analyze, and present operational quality metrics and Key Performance Indicators (KPIs) for periodic management review meetings.

Qualifications

• Education: Bachelor’s Degree or Diploma in Biomedical Engineering, Life Sciences, Biotechnology, Pharmacy, or a related scientific discipline.
• Experience: 3 to 5 years of hands-on QA experience specifically within the medical device or IVD industry, with clear experience in product development or new product introduction (NPI) phases.
• Design Control Knowledge: Strong understanding of design controls (ISO 13485 Clause 7).
• Standard &Regulatory Awareness: Solid working knowledge of documentation requirements for EU CE-IVDR (Regulation 2017/746) and HSA medical device guidelines.
• Technical Skills: Hands-on experience writing technical reports, product specifications, or verification protocols. Skilled in root-cause analysis methodologies.
• Soft Skills: High level of autonomy, exceptional attention to data integrity, and the strong communication skills needed to align technical R&D milestones with rigid quality standards.