Quality Engineer

Quality Operations Specialist / Quality Engineer

The Quality Operations Specialist / Quality Engineer will be responsible for:

Review investigations conducted by others and handle complaints submitted to them.

Perform complex investigations using deep dive root cause analysis.

Utilize TrackWise and SAP systems for quality management.

Review and perform QA for validation and investigations.

Collaborate with the validation team and project team.

Support the complex production line, focusing on true manufacturing rather than lab work.

Address deviations from manufacturing processes

Ensure compliance with QA standards and regulatory requirements.

Conduct investigations for non-conformance and utilize problem-solving tools.

Maintain strict quality standards and ask candidates about the standards they use.

Have a fundamental understanding of validation processes.

An engineering with validation experience (IQ, OQ, PQ) is ideal.

Familiarity with QA reviews, validating new equipment, and revalidation.

Review packages and checklists, providing the final signature.

Performing daily quality engineering work in manufacturing areas to provide direct support for all manufacturing activities from quality standpoint. Monitors manufacturing process verifications to ensure compliance with operating procedures and specifications. Responsible for performing process monitoring, labeling control, reinspection process monitoring and sampling process for reserved samples.

Provides quality oversight on manufacturing processes to ensure compliance including data integrity. Provides quality support for all investigations and resolution of quality issues.

Skills: Quality engineering, Quality assurance, validation, medical device, CAPA, Investigations, NCMR, FDA, change control, Quality control, root cause analysis

Top Skills Details: Quality engineering, Quality assurance, validation, medical device

Additional Skills & Qualifications: Bachelor's degree in Engineering

Experience Level: Intermediate Level

Job Type & Location: This is a Contract position based out of Irvine, CA.

Pay and Benefits: The pay range for this position is $45.00 - $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 Aug 21, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 View email address on click.appcast.io 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.