Quality Failure Analysis Engineer

East Bay, CA

Posted: 02/11/2019 Industry: IT Job Number: 855225

SUMMARY:  
This position is a contributing member of the QA team with the primary responsibility of product complaint investigation, providing timely, thorough and accurate root cause analysis of electrical and mechanical characteristics of the company products 

 
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be assigned as necessary):   
• Function as the lead complaint investigator.  Performing complaint investigations and working with cross functional teams as needed to determine root cause, ensuring all investigations are completed in timely manner. 
• Perform complaint investigations including:   analyzing returned products to understand failure mechanisms and root causes, assessing risk associated with the failures and determining need for corrective action 
• Document failure analyses in complaint records 
 • Establish root cause failure analysis techniques, processes and test methods. 
• Monitor incoming complaints and feedback, and analyze historical data to identify trends and areas for investigation and manage data for team review 
• Participate in Product Surveillance Team to monitor and develop long-term improvements to our product and test their effectiveness. 
• Present complaint data to management team 
• Work with Customer Service to obtain and communicate information with a customer in response to issues associated with complaints  
 
  
QUALIFICATIONS  
  
SKILLS and KNOWLEDGE 
• Solid understanding of and experience in applying problem-solving tools including root cause analysis, statistical tools and processes, and design of experiments. 
• Demonstrated experience evaluating, qualifying and managing failure analysis to ensure timely, complete and thorough analysis. 
• Highly proficient in use of complex lab instruments and equipment (DVM, oscilloscope, micro-vu, microscopes, forge gauge testers, audiology equipment, etc.) 
• Preferable to have computer programming and software applications knowledge. 
• Working knowledge of GMP, Post Market Surveillance, Risk Management regulations and systems. 
• Strong technical capability, verbal and written communication skills and effective interpersonal skills 
• Ability to communicate with all levels of staff and present data to management when needed 
• Ability to multitask, prioritize, handle multiple projects, meet aggressive deadlines, and work well under pressure 
• Must be able to work independently and as part of a team 
• Proficiency in MS Word,  MS Excel, and MS PowerPoint required  
  
 EDUCATION and/or EXPERIENCE: 
• BS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering or equivalent discipline 
• Minimum of 2 years of experience in the medical device industry or equivalent combination of education and experience, performing failure investigations 
• Minimum of 5 years of relevant professional experience   
• Background in electronics. sustaining engineering and/or new product development engineering 
• Working knowledge and understanding of FDA’s QSRs, ISO 13485:2003, MDD, and other national/international regulatory quality system requirements.  

 

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