Lead Software Quality Engineer – Medical Devices

TechDigital Group; Los Angeles (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

TechDigital Group in Los Angeles develops software for the medical devices domain. This senior quality-focused role requires 5+ years of product software experience and a strong command of SDLC, QMS procedures, and risk management practices.

You will lead software quality activities, CAPA investigations, and reviews of requirements, design documents, and test results, collaborating with cross-functional teams in an Agile environment.

Qualifications

• 5+ years of product software experience in Medical devices domain.
• Experience drafting Software based QMS procedures & work instructions (including third party softwares).
• Strong knowledge of SDLC, software quality, and quality management systems.
• Experience working in Agile/Scrum environments and knowledge of SDLC methodologies.
• Lead quality engineering activities, including Software risk assessments (RMF, FMEA, Cybersecurity) and Quality plan execution.
• Manage CAPA investigations, root cause analysis, corrective actions, and effectiveness monitoring.
• Review and approve requirements, design documents, test protocols, test results, and change requests.

Skills

Product software experience

SDLC

Agile/Scrum

Quality management

CAPA investigations

Risk assessment

Cybersecurity

Education

Bachelor's degree in Computer science / Software Engineering

Job description

TechDigital Group in Los Angeles develops software for the medical devices domain. This senior quality-focused role requires 5+ years of product software experience and a strong command of SDLC, QMS procedures, and risk management practices.

You will lead software quality activities, CAPA investigations, and reviews of requirements, design documents, and test results, collaborating with cross-functional teams in an Agile environment.