Quality Engineer

New Yesterday

Job Title: Quality Engineer
Job Description
The 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 Environment
This 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 Benefits
The 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 Type
This is a fully onsite position in Irvine,CA. Application Deadline
This position is anticipated to close on Aug 15, 2025.
Apply
Location:
Irvine

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