Quality Engineer II

East Bay, CA

Posted: 02/11/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008348

PURPOSE OF JOB: Responsible for supporting the quality needs of commercial and clinical operations. Responsible for the establishment and maintenance of quality assurance standards, that adheres to QSR and ISO regulations. Quality Assurance support for various Quality functions as assigned (e.g. Equipment Control and Calibration, NCMR, CAPA, Verification and Validation, Manufacturing process changes, Complaint Handling).  


  • Support the commercial and clinical manufacturing activities on the production floor 
  • Support quality Engineering support for incoming quality assurance including implementation of new inspection techniques, systems and troubleshooting. 
  • Support product lot release activities 
  • Perform NCMR investigations and related actions  
  • Perform complaint investigation and RGA analysis  
  • Develop/write protocols, coordinate the testing and write reports for validation activities, component qualification activities, IQ/OQs, gauge R&R studies 
  • Work with Manufacturing Engineering and R&D on special projects, validation activities, developing inspection /test procedures, and process improvement activities as required. 
  • Lead basic Quality Engineering projects 
  • Perform CAPA investigation and implementation of corrective actions  
  • Perform data analysis to support quality metrics 
  • Revise Quality System procedures (SOPs and WIs)  
  • Proactively identify and implement Quality System improvements 
  • Support company goals and objectives, policies and procedures, QSR, and FDA regulations 
  • Maintain accurate records/documentation related to quality, test results, and special projects 
  • Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, Good Manufacturing Practices, and FDA regulations 


  • BS degree or equivalent experience 
  • Minimum 2 years Quality Engineering or equivalent experience in medical device, pharmaceutical, or related industry. 


  • Strong written and verbal communication skills 
  • Excellent organizational and time management skills required.  
  • Experience with computer based applications (MS Word, MS Power Point, MS Excel) 


  • Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word. Standing: Remaining upright on the feet, particularly for sustained periods of time. 
  • Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. 
  • Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes. 
  • Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).

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