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 5-10 years of experience in FDA/EU regulated environments. Must have deep knowledge of ISO 13485, IEC 62304, and design control activities for Software as a Medical Device.
What they're looking for
Software Design QualitySDLCRegulatory ComplianceRisk ManagementISO 13485IEC 62304IEC 1497121 CFR Part 11
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 5-10 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, Regulatory Compliance, Risk Management, ISO 13485, IEC 62304.
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.