Quality Engineer

The Quality Engineer plays a lead role in planning, executing, and managing quality operations projects, including the generation and management of corrective and preventive actions (CCR's). This role involves working with quality operations management on improvement projects as part of remediation efforts, writing technical assessments to summarize quality-related gaps, and identifying corrective actions. The engineer collaborates closely with cross-functional teams, including product design, product management, and production, to identify and mitigate risks. Additionally, this position assists with leading and facilitating process improvement and product teams, as well as preparing and submitting technical documentation through change control and CAPA systems.

• Lead quality operations projects and manage corrective and preventive actions (CCR's).
• Collaborate with quality operations management on improvement projects as part of remediation efforts.
• Write technical assessments summarizing quality-related gaps and corrective actions.
• Work closely with cross-functional teams to identify and mitigate risks.
• Assist in leading and facilitating process improvement and product teams.
• Prepare and submit technical documentation through change control and CAPA systems.

• Proficiency in quality engineering and quality assurance.
• Experience with root cause analysis and audits.
• Familiarity with medical devices and ISO standards.
• Experience with non-conformances, investigations, and CAPA's.
• Knowledge of FDA regulations and risk mitigation strategies.
• Proficiency in NCMR, product discrepancies, and change control.
• Strong technical writing skills.

• Bachelor's degree with 2 or more years of experience in a relevant field.

The work environment is on-site in a manufacturing setting where innovative medical products and services are developed, manufactured, and marketed to the healthcare industry. These products address significant healthcare challenges such as opioid abuse, hospital-acquired malnutrition, and hazardous drug exposure. The team consists of 64 members, including technicians responsible for raw materials and finished products. The role requires good project management skills and involves reviewing drawings and procedures. This is a 12-month contract position.

This is a Contract position based out of Irvine, CA.

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)

This is a fully onsite position in Irvine,CA.

This position is anticipated to close on Jan 13, 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 : $40 - $55