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.