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.

Company Profile

Founded in 2008 by biotechnology entrepreneur Alex Thian and Sue Yap with the vision of building a leading biotechnology company, AITbiotech has grown to become a leading Molecular Diagnostic (MDx), Molecular Services and Life Science Products provider in Singapore and ASIA. AITbiotech has an ISO13485 certified laboratory. It is also bizSAFE level 3 as well as GDPMDS certified.

AITbiotech is a world leader in multiplex real-time PCR (qPCR) assays for tropical infectious diseases. Its multiplex qPCR assays, marketed under the abTESTM including the Influenza 4-plex and Dengue 4-plex assays are being used by many major hospitals in Singapore and Asean.

Focusing on using latest genomics technology tools, AITbiotech offers high quality and consistent Molecular Services to the Asian research and biomedical markets.