Quality Engineer

(none selected) | Direct Hire

Post Date: 05/26/2017 Job ID: JOS000006529 Industry: Software/Hardware
JOB SUMMARY
 The essential duties and responsibilities of Quality Engineer include the activities of Design Control, QSR Compliance, Document control, Calibration, Validation Report / Protocol review and approval, ISO 13485 activities, Training, R&D projects support and other Quality Functions.
 
ESSENTIAL FUNCTIONS
  • Responsible for developing and or reviewing key design documentation as it relates to pre-Design Control activities predominantly, but also to a lesser extent Design Control.
  • Analyzes data and writes final reports in conjunction with the R&D group.
  • Works with Engineering, Pilot line and Chemistry to ensure that test method and equipment validations (IQ, OQ and PQ) follows SOP requirements.
  • Reviews technical reports to ensure completeness, accuracy and to ensure SOP’s requirements are met.
  • Maintains Calibration System and coordinate the calibration activities and ensure equipment requiring calibration is maintained.
  • Responsible for Change Control process (DCO).
  • Ideally guide R&D project team on pre-Design Control or Design Control processes and Risk Assessments to ensure compliance to regulatory requirements.
  • Responsible for Batch Record review and approval process to ensure compliance to GMP requirements.
  • Maintains Technical Files, or DHF’s, until Design Transfer to Manufacturing
  • Responsible for managing CAPA, Deviations, and NC processes.
  • Responsible for performing internal audits to assess compliance to applicable regulatory requirements.
  • Responsible for Quality Training throughout the organization and provide companywide FDA and ISO awareness.
 
POSITION QUALIFICATIONS
 
KNOWLEDGE, SKILLS AND ABILITIES
-         Good written communication skills, time management, analytical thinking
-         Ability to work independently as well as in a cross functional team environment, including R&D, Pilot Manufacturing, Clinical and Engineering
-         Experience with clean room environment, sterilization process, and device toxicology test requirements
-         Knowledge of FDACFR 21 part 820, ISO 13485, and ideally ISO 14971 guidelines
-         Experience in interacting with Regulatory authorities regarding external audit management
-         Experience of working with document management systems such as Agile.
-         Has certified yellow or ideally green belt 6δ problem solving skills
-         Trained internal auditor, ideally in ISO 13485:2016
-         Fully familiar with MS-Office and ideally Minitab.
 

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