Sr. Software Quality Engineer

We are seeking a Senior Software Quality Engineer with extensive experience in supporting regulated medical devices. This role will focus on verification and validation activities across software, firmware, and hardware systems, ensuring compliance with FDA and international standards.

• Lead and execute Verification and Validation activities for Class II and Class III medical devices.
• Develop and maintain test plans, protocols, and reports in compliance with FDA 21 CFR 820 and IEC standards.
• Perform system-level, integration, and safety-critical testing for embedded systems.
• Conduct risk analysis and support CAPA activities.
• Collaborate cross-functionally with R&D, Systems, Manufacturing, and Regulatory teams.
• Support audits and regulatory inspections through well-documented quality artifacts.
• Contribute to the continuous improvement of quality and test processes.

• 5 years of experience in Software Quality Engineering, Test Engineering, or related discipline.
• Demonstrated experience leading Verification and Validation for regulated medical devices.
• Strong knowledge of FDA and international regulatory standards.
• Experience testing embedded systems and hardware-software integrations.
• Proficiency with test management and ALM tools.
• Strong documentation and communication skills.

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Understand Bluetooth technology and Mobile applications development.
• Experience with Class II or III medical devices.
• Working knowledge of EU MDR, MDSAP, and global regulatory requirements.
• Knowledge of risk management processes preferred.

The role involves collaboration with cross-functional teams including R&D, Systems, Manufacturing, and Regulatory. The work environment emphasizes compliance with regulatory standards, requiring meticulous documentation and communication. Dress code is professional, and the position may involve supporting audits and regulatory inspections.

This is a Contract to Hire position based out of Valencia, CA.

The pay range for this position is $57.69 - $72.12/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Valencia,CA.

This position is anticipated to close on Mar 16, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $58 - $72