Senior Quality Engineer

Senior Quality Engineer

Job Description

We are seeking a Senior 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.

Responsibilities

• 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.

Essential Skills

• 5+ years of experience in 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.

Additional Skills & Qualifications

• 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.

Work Environment

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 Apr 15, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.