Quality Complaints Engineer

Company: CYNET SYSTEMS
Location: Irvine
Posted on: March 15, 2023

Job Description:

Job Description:

Pay Range: $44.70 - $49.70

Responsibilities:

• 
  
• Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
  
• Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
  
• Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) CAPAs, SCARs, as determined by investigation.
  
• Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.
  
• Other incidental duties assigned by Leadership (may assist in Adhoc complaint analysis or metric review).
  
  Education and Experience:
  
  
  • 
    
  • Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years experience related work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1 year experience including either industry or industry/education required.
    
  • Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
    
  • Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.
    
    Additional Skills:
    
    
    • 
      
    • Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
      
    • Basic understanding of statistical techniques.
      
    • Previous experience working with lab/industrial equipment required.
      
    • Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
      
    • Solid problem-solving, organizational, analytical and critical thinking skills.
      
    • Solid understanding of processes and equipment used in assigned work.
      
    • Knowledge of and adherence to Quality systems.
      
    • Strict attention to detail.
      
    • Ability to interact professionally with all organizational levels.
      
    • Ability to manage competing priorities in a fast-paced environment.
      
    • Must be able to work in a team environment, including the ability to manage project stakeholders.
      
    • Ability to build productive internal/external working relationships.
      

Keywords: CYNET SYSTEMS, Irvine , Quality Complaints Engineer, Engineering , Irvine, California