Principal Quality Engineer

East Bay, (none selected)

Posted: 02/25/2019 Employment Type: Direct Hire Industry: IT Job Number: JOS000008051

PURPOSE OF JOB: 

Responsible for supporting the Quality Engineering needs of commercial, R&D and clinical operations. Lead various Quality functions as assigned (e.g. NCMR, CAPA, Manufacturing Process changes, Verification and Validation). 

MAJOR DUTIES AND RESPONSIBILITIES: 

  • Manage the non-conforming material (NCMRs) system.  
  • Manage cleanroom environmental monitoring program  
  • Manage return goods product (RGA) system  
  • Support the daily commercial manufacturing activities and work with Manufacturing Engineers to resolve line issues and implement corrective actions.  
  • Provide technical support for incoming inspection activities and lot release testing activities  
  • Lead complex Quality engineering projects or cross-functional projects as assigned including developing project plans and facilitating the completion of all necessary activities.  
  • Develop and revise Quality System procedures (SOPs and WIs).  
  • Provide strong technical expertise for non-conforming material (NCMRs) and corrective and preventive actions (CAPAs) investigations.  
  • Lead the investigation and closure of product complaints  
  • Create and maintain Quality Plans for Quality Engineering activities and special projects  
  • Develop test methods and lead test method validation activities.  
  • Develop/write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, gauge R&R studies as necessary  
  • Responsible for maintaining risk management files for commercial products  
  • Facilitates problem solving, root cause analysis, and other continuous improvement initiatives.  
  • Provide technical guidance for sterilization validation activities  
  • Provide technical guidance for complex engineering issues to less experience engineers.  
  • Provide statistical data analysis and interpretation guidance support for investigations, specification setting activities, and test protocols  
  • Participate in inspections for FDA, FDB, ISO, MDD, and other regulatory agencies  
  • 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. 

EDUCATION /EXPERIENCE REQUIREMENTS: 

  • Bachelor's degree in Engineering/Life Sciences and a minimum of 8 years’ medical device experience.  
  • Experience with quality system elements pertaining to combination products (drug/device) and QSR, cGMP and ISO 13485 familiarity is required. 

OTHER QUALIFICATIONS: 

  • Strong written and verbal communication skills and attention to detail.  
  • Must work independently and have the ability to mentor junior quality associates.  
  • Self-Starting, detail oriented, quick learner, creative and analytical.  
  • Capable of understanding and analyzing complex engineering problems.  
  • Some travel may be required. 

Physical Activities: 

Walking: Moving about on foot to accomplish tasks, particularly for long distances or moving from one work site to another. 

Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. 

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, and Working Conditions: 

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. 

The worker is subject to inside environmental conditions: Protection from weather conditions but not necessarily from temperature changes. 

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