Quality Engineer - Medical Devices

Job Title: Quality Engineer - Medical Devices

Location: Irvine, CA - 92614

Duration: 12 Months

Overview

We are seeking a motivated Quality Engineer to join our team in the medical devices sector. The ideal candidate will be responsible for investigating customer complaints, ensuring compliance with quality engineering principles, and contributing to continuous process improvement. This role requires strong analytical skills, teamwork, and a solid understanding of regulatory requirements.

Responsibilities

• Conduct thorough investigations of customer complaints, providing detailed analyses of processes and data.
• Determine root causes of nonconformities and establish corrective and preventive actions.
• Collaborate with multifunctional teams to systematically address complaints and ensure timely resolutions.
• Ensure that complaint investigations meet applicable procedures and regulatory requirements.
• Investigate moderately complex manufacturing quality and compliance issues (e.g., CAPA, non-conformances, audit observations) prior to product release.
• Develop, update, and maintain the technical content of risk management files.
• Optimize manufacturing processes using engineering methods (e.g., Six Sigma, Lean) for design and continuous improvement.
• Identify opportunities for the redesign of equipment, tools, and fixtures to enhance manufacturing processes and mitigate risks.
• Analyze results, make recommendations, and develop comprehensive reports.
• Create training and documentation materials (e.g., work instructions) for production teams to facilitate seamless knowledge transfer.
• Assign support tasks and provide guidance to technicians on conducting tests.
• Train and provide feedback to technicians, coordinating their work as needed.
• Build productive working relationships with internal teams, vendors, and project stakeholders.
• Adhere to all company protocols, including pandemic guidelines and Environmental Health & Safety rules.
  
  

Skills

• Strong documentation, communication, and interpersonal relationship skills, including negotiation and relationship management.
• Basic understanding of statistical techniques and solid knowledge of engineering principles and concepts.
• Proficient in processes and equipment used in assigned work areas.
• Familiarity with Quality Management Systems (QMS) and adherence to quality systems.
• Strong problem-solving, organizational, analytical, and critical thinking abilities.
• Experience with lab/industrial equipment is preferred.
• Proficiency in computer applications and engineering software, including Computer-Aided Design (CAD).
  
  

Education And Experience

• Bachelor’s degree in engineering (required).
• 1-4 years of relevant experience in quality engineering or related fields (required).
  
  

Additional Requirements

• Ability to interact professionally with all organizational levels.
• Team-oriented with the capacity to manage vendors and project stakeholders.
• Commitment to safety and environmental protection within the workplace.