Quality Assurance Engineer

San Jose, CA 95134

Employment Type: Direct Category: Quality Engineer Job Number: 7847

Qualifications:

  • BSME, MS preferred
  • Must have medical device experience or previous experience in regulated field 
  • Demonstrated experience with Risk analysis, Risk control methods
  • Experience working under Design Control Process
  • 21 CFR 820, ISO 13485, ISO 14791
  • Knowledge of statistical methodologies, quality control
  • Experience with CAPA, NCMR (non-conforming material report) causes, corrective actions/dispositions
  • Experience with IQ, QQ, PQ protocols
  • Understanding of lean manufacturing, Six Sigma, statistical analysis etc. - MasterControl, SmartCAPA, Oracle, Crystal Reports

Responsibilities:

  • Anticipate and identify potential manufacturability or reliability problems utilizing sophisticated research techniques; may require novel solutions
  • Manage ECN’s for all stages of manufacturing process  
  • Analyze nonconformance records to determine corrective actions, root cause, etc. -
  • Coordinate and supervise engineers and technicians on engineering projects; evaluate methods of Quality Auditors, Quality Engineers, technicians 
  • Excellent communication skills and ability to delegate tasks

 

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