Job Information
Actalent Quality Engineer in Irvine, California
Job Title: Quality EngineerJob Description
The Quality Engineer plays a lead role in planning, executing, and managing quality operations projects, including generation and CCRs. This role involves collaborating with quality operations management on improvement projects as part of remediation efforts. The Quality Engineer is responsible for writing technical assessments that summarize quality-related gaps and identify corrective actions. This position requires close collaboration with cross-functional teams, including product design, product management, and production, to identify and mitigate risks. Additionally, the Quality Engineer assists with leading and facilitating process improvement and product teams and prepares and submits technical documentation through change control and CAPA systems.
Responsibilities
Plan, execute, and manage quality operations projects, including generation and CCRs.
Collaborate with quality operations management on improvement projects.
Write technical assessments summarizing quality-related gaps and corrective actions.
Work closely with cross-functional teams to identify and mitigate risks.
Lead and facilitate process improvement and product teams.
Prepare and submit technical documentation through change control and CAPA systems.
Essential Skills
Quality engineering
Quality assurance
Root cause analysis
Audit
Medical device knowledge
Technical writing
ISO standards
Non-conformances management
Investigations
CAPA systems
FDA compliance
Risk mitigation
NCMR management
Engineering expertise
Additional Skills & Qualifications
2 or more years of relevant experience
Bachelor's degree
Strong writing skills
Work Environment
This role is based in an on-site manufacturing setting, where the company develops, manufactures, and markets innovative medical products and services to the healthcare industry. The team consists of 64 members, including technicians, supervisors, and other personnel, working with both finished products and raw materials. The work environment is dynamic and project-oriented, with a focus on reviewing drawings and procedures. The company is in a growth phase, offering significant opportunities for career advancement. The position is initially for 12 months, with the potential for extension based on performance.
Job Type & Location
This is a Contract to Hire position based out of Irvine, CA.
Pay and Benefits
The pay range for this position is $40.00 - $55.00/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 fully onsite position in Irvine,CA.
Application Deadline
This position is anticipated to close on Apr 29, 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.