"Alerted.org

Quality Engineer

Employment Type: 12-Month Contract

About the Role

We are seeking a detail-oriented Quality Engineer to lead quality operations projects and drive continuous improvement initiatives within a dynamic manufacturing environment. This role is critical in ensuring compliance with regulatory standards and maintaining the highest level of product quality for innovative medical solutions that improve patient care and safety.

As a Quality Engineer, you will manage corrective and preventive actions (CCR’s), collaborate with cross-functional teams, and contribute to process improvement efforts. You’ll play a key role in risk mitigation, technical documentation, and supporting remediation projects that strengthen operational excellence.

About the Company

A global leader in developing and manufacturing advanced medical products and services that address critical healthcare challenges, including opioid abuse prevention, hospital-acquired malnutrition, and hazardous drug exposure. Our mission is to improve patient outcomes and enhance safety across healthcare settings. With a strong commitment to innovation, quality, and compliance, we foster a collaborative environment where professionals can make a meaningful impact. Our team combines technical expertise with a passion for improving lives, delivering solutions trusted by healthcare providers worldwide.

Responsibilities

+ Lead quality operations projects and manage corrective and preventive actions (CCR’s).

+ Collaborate with quality operations management on remediation and improvement initiatives.

+ Write technical assessments summarizing quality-related gaps and corrective actions.

+ Work closely with product design, product management, and production teams to identify and mitigate risks.

+ Facilitate process improvement and product teams.

+ Prepare and submit technical documentation through change control and CAPA systems.

Essential Skills

+ Proficiency in quality engineering and assurance principles.

+ Experience with root cause analysis and audits.

+ Familiarity with medical devices and ISO standards.

+ Expertise in non-conformances, investigations, and CAPA processes.

+ Knowledge of FDA regulations and risk mitigation strategies.

+ Strong technical writing skills and documentation experience.

Additional Qualifications

+ Bachelor’s degree with 2+ years of relevant experience.

+ Proficiency in NCMR, product discrepancies, and change control systems.

Work Environment

This is an on-site role in a manufacturing setting where innovative medical products are developed and produced. You’ll join a team of 64 professionals, including technicians responsible for raw materials and finished products. The position requires strong project management skills and involves reviewing drawings and procedures to ensure compliance and quality standards.

Ready to make an impact? Apply today and join a team dedicated to advancing healthcare through innovation and quality.

Job Type & Location

This is a Contract 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 Jan 14, 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 [email protected] (%[email protected]) for other accommodation options.