Quality Engineer

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.
3 days ago