Quality Engineer

2 days ago

Irvine, United States Hydrogen Group Full time

Quality Engineer

Irvine, CA

Schedule: Standard Office Hours

Duration: 6-Month Contract

Pay range: $35.00 - $40.00

Job Responsibilities: In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include:

  • Leading multiple quality-related projects, including:
    • Investigating customer complaints for medical devices.
    • Analyzing manufacturing processes and data.
    • Implementing corrective and preventive actions.
    • Driving continuous improvement in product quality and compliance.
  • Ensuring compliance with applicable quality standards and regulatory requirements for medical devices.
  • Collaborating with cross-functional teams and stakeholders to ensure project success.



Essential Duties and Job Functions:

  • Perform thorough investigations of customer complaints, providing detailed analysis of processes and data.
  • Execute complaint investigations using a multifunctional approach, addressing issues systematically.
  • Oversee all phases of complaints requiring investigation, ensuring timely completion.
  • Collaborate closely with investigation owners to resolve issues and address overdue cases.
  • Verify that complaint investigations are adequate and comply with applicable procedures.
  • Apply quality engineering principles to ensure regulatory compliance and optimize product development, manufacturing, and distribution processes.
  • Investigate moderately complex manufacturing quality and compliance issues for all production processes.
  • Optimize manufacturing processes using engineering methods like Six Sigma and Lean.
  • Develop and maintain technical content of risk management files.
  • Create training and documentation materials for production processes.
  • Assign and coordinate tasks for technicians, providing guidance and feedback.



Knowledge & Skills:

  • Strong documentation, communication, and interpersonal skills.
  • Basic understanding of statistical techniques.
  • Experience working with laboratory/industrial equipment.
  • Solid understanding of engineering principles, theories, and concepts.
  • Strong problem-solving, organizational, analytical, and critical thinking skills.
  • Thorough understanding of processes and equipment used in assigned work.
  • Knowledge of and adherence to quality systems.
  • Meticulous attention to detail.
  • Ability to interact professionally with all organizational levels.
  • Capability to manage competing priorities in a fast-paced environment.
  • Proficiency in teamwork, including vendor and stakeholder management.
  • Ability to build productive internal/external working relationships.
  • Adherence to all company rules and requirements (e.g., safety protocols).
  • Proficiency with computer applications and software related to engineering, such as CAD.



Education & Experience:

  • Bachelor's degree in Engineering.
  • 0-2 years of relevant experience.
  • Experience in medical device industry preferred.
  • Familiarity with quality systems and regulatory requirements for medical devices is highly desirable.
  • Certification in quality engineering or related field is a plus.

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