Sr. R&D Quality Engineer

San Jose, CA 95134 | Direct

Job ID: 7847 Category: Quality Engineer

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

 

quality, design control, stents, statistical analysis, verification, validation, ISO 13485, IQ, QQ, PQ, risk analysis, CAPA, 21 CFR 820, ISO 14791, six sigma, lean manufacturing, MasterControl, SmartCAPA, Oracle, Crystal Reports, NCMR, Non-Conforming Material Report

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