Senior QA Executive - IVD Design Control & Compliance

AITBIOTECH PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

AITbiotech Pte Ltd in Singapore is seeking a Senior Quality Assurance Executive to own the design control system for our IVD product development program. You will work across R&D, bioinformatics and production to ensure quality from concept to release under ISO 13485 and regulatory frameworks.

This hands-on role covers risk management, validation, PMS, CAPA and documentation. You will manage design history files, change control, and liaise with external auditors as we prepare for HSA/EU IVDR

Qualifications

• 3+ years in QA/QA-RA at a medical device or IVD manufacturer within an ISO 13485 quality system.
• Direct experience with design control documentation, validation protocols and reports, or CAPA and change control.
• Working knowledge of ISO 13485 and ISO 14971.
• Experience documenting and authoring controlled documents: SOPs, protocols, validation reports, risk assessments.

Responsibilities

• Build the quality system for design and development, including SOPs and forms for design control, change control and risk management.
• Run design control on live projects; manage Design History File, design reviews, and revalidation decisions.
• Draft and close validation protocols and reports with R&D and bioinformatics teams; maintain risk management files per ISO 14971.
• Maintain Device Master Record elements and PMS processes; support regulatory submissions (HSA/EU IVDR).
• Coordinate internal audits, CAPA, nonconformity and supplier quality activities.

Skills

QA experience

ISO 13485 knowledge

Design control

CAPA & change control

Documentation writing

External audits

English writing

Molecular biology terminology

Education

Degree in life sciences or related field

Job description

AITbiotech Pte Ltd in Singapore is seeking a Senior Quality Assurance Executive to own the design control system for our IVD product development program. You will work across R&D, bioinformatics and production to ensure quality from concept to release under ISO 13485 and regulatory frameworks.

This hands-on role covers risk management, validation, PMS, CAPA and documentation. You will manage design history files, change control, and liaise with external auditors as we prepare for HSA/EU IVDR