About this role
Lead software design quality and compliance for medical device software across the entire SDLC. Drive process improvements in cybersecurity and risk management while ensuring adherence to FDA and EU regulatory standards.
Requires a BS in computer science, engineering, or biology with 8-10 years of experience in FDA/EU regulated environments. Must have deep knowledge of ISO 13485, IEC 62304, and software design control activities.
What they're looking for
Software Design QualitySDLCISO 13485IEC 6230421 CFR 820IEC 14971Cybersecurity StandardsQMS
Frequently asked questions
What does a Software Design Quality Assurance Staff Engineer at Thermo Fisher Scientific do?
Lead software design quality and compliance for medical device software across the entire SDLC. Drive process improvements in cybersecurity and risk management while ensuring adherence to FDA and EU regulatory standards. Requires a BS in computer science, engineering, or biology with 8-10 years of e…
What skills does this Software Design Quality Assurance Staff Engineer role need?
Key skills for this role include Software Design Quality, SDLC, ISO 13485, IEC 62304, 21 CFR 820, IEC 14971.
How much does a Software Design Quality Assurance Staff Engineer at Thermo Fisher Scientific pay?
The employer did not list a salary for this role. Most similar Singapore roles publish their band on the job page.
Is this Software Design Quality Assurance Staff Engineer role remote, hybrid, or on-site?
This role is on-site, based in Singapore.
How do I apply for this Software Design Quality Assurance Staff Engineer role?
You can apply directly on Thermo Fisher Scientific's careers page. ApplyLah can tailor your résumé and cover letter to this exact role in seconds first.