Quality Engineer

Actalent

  • Irvine, CA
  • $50.00-55.00 per hour
  • Contract
  • Full-time
  • 2 days ago
Job Title: Quality Engineer
Job DescriptionThe Quality Specialist plays a lead role in planning, executing, and managing quality operations projects, including generation and CCR's. This position involves working closely with quality operations management on improvement projects as part of remediation efforts. The role includes writing technical assessments summarizing quality-related gaps and identified corrective actions. The specialist collaborates with cross-functional teams, such as product design, product management, and production, to identify and mitigate risks. Additionally, the specialist assists with leading and facilitating process improvement and product teams, preparing and submitting technical documentation through change control and CAPA systems.Responsibilities
  • Lead the planning, execution, and management of quality operations projects.
  • Work with quality operations management on improvement projects as part of remediation efforts.
  • Write technical assessments summarizing quality-related gaps and identified corrective actions.
  • Collaborate with cross-functional teams to identify and mitigate risks.
  • Assist with leading and facilitating 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 investigations
  • CAPA's
  • FDA regulations
  • Risk mitigation
  • NCMR
  • Product discrepancies
  • Change control
Additional Skills & Qualifications
  • Bachelor's degree with 2 or more years of experience
Work EnvironmentThis role is based in an on-site manufacturing environment where innovative medical products and services are developed, manufactured, and marketed to the healthcare industry. The work involves addressing significant healthcare challenges, including opioid abuse, hospital-acquired malnutrition, and hazardous drug exposure. The team consists of 64 members, including technicians and supervisors, who handle tasks related to raw materials, finished products, and the plastic team. The position requires reviewing drawings and procedures, and it is a 12-month contract.Pay and BenefitsThe pay range for this position is $50.00 - $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 TypeThis is a fully onsite position in Irvine,CA.Application DeadlineThis position is anticipated to close on Sep 16, 2025.About ActalentActalent 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 for other accommodation options.

Actalent