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Operations Quality Engineer
Ref No.: 18-32420
Location: Sylmar, California
Position Type:Contract
Start Date: 05/10/2018
Job Description:
  • Knowledge of Medical Device Quality Systems (CFR 820)
  • Experience and knowledge of nonconforming product methodologies/processes (i.e. bracketing and containment, product investigations, triggers, good documentation practices)
  • Experience with writing and maintaining NCMR records
  • Quality Engineering experience supporting Operations (i.e. Operations QE, not Development QE)
  • Quality Plan/Protocol author experience
  • Engineering Degree
  • Approx. 5 years experience in Medical Device
  • Product experience with active implantable devices (prefer pacemaker/ICD experience)
Major Responsibilities
  • Retrospective review of NCMRs to identify gaps
  • Remediation of Record (coordination with cross functional team; update of record to address gaps)
  • Record assessment
  • Assessment of records to identify inclusion/exclusion
  • Develop Quality Plans to manage execution of remediation activities
  • Execute on noted remediation activities