Senior QA Executive - IVD Design Control & Compliance

AITBIOTECH PTE. LTD.

Singapore

On-site

SGD 60,000 - 90,000

Full time

14 days+

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

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.