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Quality Engineer

Quality Engineer

ActalentIrvine, CA, US
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Design Assurance Quality Engineer

This position is responsible for supporting electrode product and process sustaining activities through the application of Quality engineering skills for medical devices. Focuses on process, equipment, and design verification and validations; working with teams to develop manufacturing and quality processes and define their related tools; troubleshooting and support of manufacturing floor and field issues, and review and approve validations.

Essential Functions

  • Review and approve verification and validation protocols and reports.
  • Participate in Change Control review and approval activities as required.
  • Provide technical guidance and oversight to Quality Engineers.
  • Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971.
  • Develop and implement quality plans.
  • Ensure post market surveillance reviews are conducted and reports documented according to schedule.
  • Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues.
  • Provide key quality trending information and data for Management Review and monthly KPI review, as applicable.
  • Represent quality interests and concerns on project teams.
  • Investigate causes of quality and yield problems identified in the field and throughout the manufacturing and testing processes.
  • Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools / principles, such as process validation, equipment, test methods, root cause analysis, risk mitigation, process improvement tools, sampling plans, etc.
  • Provide support during regulatory audits and responses to government agency questions.

Required / Preferred Education and Experience

  • Bachelor's Degree in Engineering or technical discipline required
  • 5 Years medical device experience required

    • Knowledge, Skills and Abilities

  • Proficient with Microsoft Office Suite
  • Familiarity with mechanical and electrical test equipment
  • Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing
  • Working knowledge of EN ISO 13485, ISO 14971, IEC 62304 and FDA QSR for Medical Devices
  • Ability to work in a fast-paced environment
  • High energy problem solver capable of driving items to closure
  • Excellent communication and interpersonal skills (verbal, written and presentation). Understands how to present information dependent on the level of the audience.
  • Ability to effectively manage time, balance multiple task assignments and translate quality requirements into product specifications

    • Pay and Benefits

    The pay range for this position is $60.00 - $70.00 / 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 hybrid position in Irvine, CA.

    Application Deadline

    This position is anticipated to close on Sep 3, 2025.

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    Quality Engineer • Irvine, CA, US