Senior Software Quality Engineer

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

An innovative and rapidly growing medical device organization is seeking a Senior Software Quality Engineer to play a critical role in ensuring the quality, compliance, and successful release of software products supporting both medical device applications and manufacturing operations.

This position offers the opportunity to work closely with cross-functional teams across product development, quality, regulatory, and engineering while helping bring life-changing technologies to market.

What You'll Do

• Lead quality engineering activities supporting Software as a Medical Device (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 the 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.

What We're Looking For

• 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.

Preferred Qualifications

• Advanced degree in a technical discipline.
• Certified Quality Engineer (CQE) or equivalent certification.
• Experience supporting Software as a Medical Device (SaMD) products.
• Background in ophthalmology, vision care, or other highly regulated medical device sectors.

Why Consider This Opportunity?

This is an opportunity to join a well-established medical device innovator developing technologies that positively impact patients around the world. You'll work alongside accomplished engineering, quality, and regulatory professionals while helping shape the quality strategy for critical software products and future innovations.

If you are passionate about medical device software quality, regulatory compliance and partnering with development teams to deliver safe and effective products, we'd love to connect.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.