Senior QA Engineer - Medical Device Compliance (Onsite Irvine)

Glidewell Dental; Irvine (CA); On-site; USD 95,000 - 130,000; Full time

Job summary

Glidewell Dental is seeking a Senior Software Compliance Engineer to guide regulatory interpretation and ensure software products meet FDA QSR and ISO 13485 requirements. You will work with cross-functional teams on software lifecycle documentation, risk management, and usability standards.

You will collaborate with development teams to implement compliant solutions, review test protocols, and maintain regulatory knowledge to support on-site software at our Irvine campus.

Qualifications

• Bachelor’s degree in a relevant technical field or equivalent experience.
• 8+ years software engineering experience in FDA QSR/ISO 13485 medical device industry.
• Experience applying IEC 62304, ISO 14971, IEC 60601, and IEC 62366 usability engineering.
• Experience with Agile methodologies (Scrum/Kanban) and non-embedded/web development.
• Cloud-based software experience preferred.

Responsibilities

• Provides guidance interpreting policies and regulations to assure compliance.
• Partners with SDLC teams on documentation including requirements, design, RMF, tests and traceability.
• Participates in QMS activities compliant with FDA QSR and ISO 13485.
• Contributes to software risk management including cybersecurity feedback.
• Keeps current on regulations to support software compliance.
• Guides development teams in finding compliant solutions and alternatives.
• Conducts testing and evaluates software against standards and performance guidelines.

Skills

Regulatory compliance

SDLC collaboration

Quality standards

Agile methodologies

Web development

Education

Bachelor’s degree in Computer Science/Software Engineering/Informatics/Biomedical or related field

Tools

IEC 62304

ISO 14971

IEC 60601

IEC 62366 Usability Engineering

Job description

Glidewell Dental is seeking a Senior Software Compliance Engineer to guide regulatory interpretation and ensure software products meet FDA QSR and ISO 13485 requirements. You will work with cross-functional teams on software lifecycle documentation, risk management, and usability standards.

You will collaborate with development teams to implement compliant solutions, review test protocols, and maintain regulatory knowledge to support on-site software at our Irvine campus.