Software Quality Engineer

Software Quality Engineer

Job Description

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

Responsibilities

• Execute Verification and Validation (V&V) 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 Corrective and Preventive Actions (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.

Essential Skills

• 5-10 years of experience in Software Quality Engineering, Test Engineering, or a related discipline.
• Demonstrated experience leading V&V for regulated medical devices.
• Strong knowledge of FDA regulatory standards.
• Experience testing embedded systems and hardware-software integrations.
• Proficiency with test management and Application Lifecycle Management (ALM) tools.
• Strong documentation and communication skills.

Additional Skills & Qualifications

• Bachelor's degree in engineering, Life Sciences, or a related field.
• 5+ years of hands-on medical device testing experience.
• Experience with verification and validation (V&V) and related documentation.
• Direct experience testing software that interacts with a physical medical device.
• Experience creating and executing test cases, test plans, and test documentation.
• Understanding of Bluetooth technology and mobile applications development.
• Working knowledge of EU MDR, MDSAP, and global regulatory requirements.
• Knowledge of risk management standards and ISO standards.

Work Environment

The role involves working with regulated medical devices, requiring adherence to strict compliance and regulatory standards. The environment is collaborative, involving cross-functional teams including R&D, Systems, Manufacturing, and Regulatory. It includes hands-on testing of embedded systems and requires strong documentation skills.

Job Type & Location

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

Pay and Benefits

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)

Workplace Type

This is a hybrid position in Valencia,CA.

Application Deadline

This position is anticipated to close on Jun 12, 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 process due to a disability, please email ... for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.