Senior Quality Assurance Executive - IVD Product Development
AITbiotech Pte Ltd . Singapore . Full-time, permanent
About the role
At AITbiotech, we develop innovative molecular diagnostics and genomics solutions spanning qPCR, targeted sequencing, and integrated automation workflows.
We're looking for a QA professional to take ownership of quality for this new product development programme: design control across the development pipeline, and manufacturing quality for the kits we produce and release under our own name.
It's a broad, hands-on role in a small team. You'll work directly with R&D, bioinformatics and production, and you'll own the quality documentation that carries our products through HSA and EU IVDR registration.
If you're three to five years into a QA career and want scope beyond one product and one process step, this is the jump - the kind of breadth that takes considerably longer to reach in a large organization.
Key Responsibilities
Build the quality system for design and development
- Work with our external consultant on the gap analysis and procedure architecture, then own the system it produces
- Write and control the SOPs, templates and forms for design control, change control and risk management
- Manage the ISO 13485 scope extension: application, certification body liaison, audit preparation, findings closure
Run design control on live projects
- Own and control the Design History File for each product line - design plans, inputs, outputs, reviews, traceability matrices to ensure completeness and compliance with ISO 13485.
- Coordinate and minute design review gates with R&D and bioinformatics
- Manage design change control, including impact assessment and revalidation decisions
- Draft and close validation protocols and reports with R&D team
Risk and validation documentation
- Build and maintain risk management files in accordance to ISO 14971
- Draft, issue and close out validation protocols and reports with the scientists who generate the data
- Maintain the software documentation file for our bioinformatics pipeline (IEC 62304 - we'll train you if this is new)
Keep the system running
- Create, maintain and control the Device Master Record not limiting to specifications, drawings, production and assembly instructions, labeling, and packaging and QA procedures together with R&D team.
- Design and operate the Post-Market Surveillance (PMS) together with Regulatory Assurance, not limiting to complaint handling, vigilance reporting, CAPA, trend analysis and periodic safety update reports (PSUR).
- Document controls for documentation not limiting to the Device Master Record, CAPA, nonconformity, complaint handling,
- Maintain Supplier quality: qualification records, quality agreements, incoming acceptance criteria
- Control Manufacturing SOPs, work instructions and ensure updates are reviewed and approved.
- Internal audit programme, management review, training records
- Support HSA and EU IVDR submissions - technical documentation structure, GSPR checklists, ASEAN CSDT dossiers
What we're looking for
Essential
- Degree in life sciences, biomedical engineering, biotechnology or a related field
- 3+ years in QA or QA/RA at a medical device or IVD manufacturer, working hands-on inside an ISO 13485 quality system
- Direct experience with at least one of: design control documentation, validation protocol and report writing, or CAPA and change control
- Working knowledge of ISO 13485 and ISO 14971
- Practical experience building and maintaining risk management file, integrating risk controls into design, manufacturing, and post-market surveillance activities.
- You have personally authored controlled documents - SOPs, protocols, validation reports, risk assessments - not only filed and distributed them
- Involvement in at least one external audit or regulatory inspection, in any supporting capacity
- Clear, precise written English. This role is judged on documents that auditors read it matters more here than in most QA jobs
- Comfortable with molecular biology terminology (PCR, NGS) - enough to talk to scientists about what they're validating
Advantageous, not required
- IVD specifically, rather than general medical devices
- HSA medical device registration experience, or exposure to EU IVDR / MDR
- IEC 62304 or software-as-a-medical-device documentation (genuinely rare - we'll train the right person)
- ISO 13485 internal auditor or lead auditor certification
- Experience with NGS or qPCR assay validation, or with clinical performance studies (ISO 20916 / ISO 15189)
What you get
- Ownership. You will be the person who builds AITbiotech's design control system, and your name will be on it.
- Breadth. Four product lines - NGS, qPCR, extraction, software - instead of one narrow corner of one product.
- Support where it counts. External consultant time is budgeted for the system architecture and certification body strategy, so you're not doing this from a standing start alone. Direct working relationship with the R&D Director.
- A defined growth path, including toward Person Responsible for Regulatory Compliance under EU IVDR as our EU route matures.
- Small company, real decisions, short distance between your work and whether the product ships.
