Senior SaMD Quality Engineer - Medical Device Software

Real Staffing; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Real Staffing is seeking a Senior Software Quality Engineer to lead quality activities for SaMD and manufacturing software in a fast-growing medical device company. You will collaborate with product development, quality, regulatory, and engineering teams to ensure compliant design controls, risk management, verification and validation, and successful product releases across life-changing technologies.

The ideal candidate has 5+ years of medical device software experience and a proven track

Qualifications

• Bachelor's degree in Engineering, Life Sciences, CS, or related field.
• 5+ years in software quality engineering within the medical device industry.
• Strong understanding of FDA QSR and ISO 13485.
• Experience supporting software change management processes.
• Knowledge of IEC 62304 and IEC 82304.
• Experience with risk management, FMEA, CAPA, and software validation.
• Strong technical writing, documentation, and PM skills.
• Ability to influence cross-functional teams.

Responsibilities

• Lead quality engineering activities for SaMD, quality system software, and manufacturing software platforms.
• Provide expertise across the software development lifecycle: design controls, risk management, verification and validation, maintenance, change management.
• Partner with engineering and product teams to ensure compliant and efficient software releases.
• Drive software quality initiatives through risk assessments, investigations, CAPA, and continuous improvement.
• Review and approve design control docs, validation strategies, and quality deliverables.
• Support software nonconformance investigations and customer complaint assessments.
• Provide leadership in quality system compliance and regulatory requirements in a highly regulated environment.

Skills

Software quality engineering

FDA/ISO 13485

Software validation

Risk management (FMEA)

Technical writing

Project management

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science, or related technical field

Tools

IEC 62304

IEC 82304

CAPA system

Job description

Real Staffing is seeking a Senior Software Quality Engineer to lead quality activities for SaMD and manufacturing software in a fast-growing medical device company. You will collaborate with product development, quality, regulatory, and engineering teams to ensure compliant design controls, risk management, verification and validation, and successful product releases across life-changing technologies.

The ideal candidate has 5+ years of medical device software experience and a proven track