Design Assurance Quality Engineer

Design Assurance Quality Engineer

Location:

Irvine, CA

Schedule:

Hybrid (2-days in Office per week: Monday and Tuesdays)

Compensation: $60-$75/hr (Negotiable based upon experience)

A global leader in developing advanced medical technologies that help save lives and improve patient outcomes. Company innovative solutions—including devices, software, and services—are trusted by hospitals, emergency services, and military organizations worldwide. From cardiac care to respiratory support, their mission is to deliver products that make a meaningful difference in critical moments.

The Senior Design Assurance Quality Engineer will support electrode product and process sustaining activities by applying quality engineering principles to ensure compliance with regulatory standards and internal requirements. This role focuses on process, equipment, and design verification and validation, while providing technical leadership and guidance to cross‑functional teams.

• Review and approve verification and validation protocols and reports.
• Participate in change control review and approval activities.
• Provide technical guidance and oversight to Quality Engineers.
• Lead risk management activities, including development and maintenance of risk files in compliance with ISO 14971.
• Develop and implement quality plans for products and processes.
• Ensure timely completion of post‑market surveillance reviews and documentation.
• Participate in CAPA investigations using systematic problem‑solving methodologies.
• Provide quality trending data for management reviews and KPI reporting.
• Represent quality interests on project teams and during regulatory audits.
• Investigate root causes of quality and yield issues in manufacturing and field environments.
• Apply quality engineering tools such as process validation, equipment qualification, test method validation, sampling plans, and risk mitigation strategies.

• Education:
  
  Bachelor’s degree in Engineering or a technical discipline required.
• Experience:
  
  Minimum 5 years in medical device quality engineering.
• Skills & Knowledge:
  • Proficient in Microsoft Office Suite.
  • Familiarity with mechanical and electrical test equipment.
  • Strong understanding of medical device manufacturing practices.
  • Working knowledge of EN ISO 13485, ISO 14971, IEC 62304, and FDA QSR.
  • Excellent communication and interpersonal skills.
  • Ability to manage multiple priorities in a fast‑paced environment.
  • High‑energy problem solver with strong analytical skills.

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

The pay range for this position is $60.00 - $75.00/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 hybrid position in Irvine, CA.

This position is anticipated to close on Jan 16, 2026.

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 actalentaccom for other accommodation options.