Senior Software Quality Engineer — SaMD & Regulatory Lead

Real; Irvine (CA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Paid leave

Job summary

Real, a medical device organization in Irvine, seeks a Senior Software Quality Engineer to drive quality across SaMD and manufacturing software, ensuring compliant releases and robust validation.

You will collaborate with product development, quality, regulatory, and engineering teams to advance software quality initiatives, risk management, and CAPA activities in a highly regulated environment.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Computer Science, or a related technical field.
• 5+ years of experience in software quality engineering, validation, design controls, or quality assurance within the medical device industry.
• Strong understanding of FDA Quality System Regulations and ISO 13485.
• Experience supporting software change management processes.
• Working knowledge of medical device software standards, including IEC 62304 and IEC 82304.
• Experience with risk management methodologies, FMEA, CAPA, and software validation activities.
• Strong technical writing, documentation, communication, and project management skills.
• Ability to influence cross‑functional teams and drive quality initiatives in a collaborative environment.

Responsibilities

• Lead quality engineering activities supporting SaMD, quality system software, and manufacturing software platforms.
• Provide expertise throughout the software development lifecycle, including design controls, risk management, verification and validation, maintenance, and change management.
• Partner with engineering and product development teams to ensure compliant and efficient release of software products.
• Drive software quality initiatives through risk assessments, investigations, root cause analysis, CAPA activities, and continuous improvement efforts.
• Review and approve design control documentation, validation strategies, and quality deliverables for new product development programs.
• Support software nonconformance investigations, customer complaint assessments, and technical troubleshooting efforts.
• Provide leadership in quality system compliance and regulatory requirements within a highly regulated medical device environment.

Skills

Software quality engineering

Design controls

Risk management

CAPA

Regulatory compliance

Technical writing

Project management

Education

Bachelor’s degree in Engineering/Life Sciences/CS

Tools

CAPA systems

FMEA

Job description

Real, a medical device organization in Irvine, seeks a Senior Software Quality Engineer to drive quality across SaMD and manufacturing software, ensuring compliant releases and robust validation.

You will collaborate with product development, quality, regulatory, and engineering teams to advance software quality initiatives, risk management, and CAPA activities in a highly regulated environment.