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JENAVALVE TECHNOLOGY INC

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Engineer I, Quality (THV)

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Job Title: Engineer, Quality (THV)

  • Engineer I, Quality (THV)
  • Engineer II, Quality (THV)
  • Engineer III, Quality (THV)

Role Level: Individual Contributor

Supervisor/Manager Title: Senior Manager, Quality Engineering

Job Location & Environment: Irvine, CA- Corporate office / Controlled Cleanroom Environment

Job Description Summary:

  • Provide regular Quality Engineering support to transcatheter Heart Valve (THV) manufacturing and relevant areas including design Verification and Validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance identification/initiation/investigation, risk management, and post-market assessment.

Job Responsibilities:

  • Partner with Manufacturing Engineers to characterize and qualify manufacturing processes.
  • Provide technical Quality support to ensure new processes/procedures are in compliance with the governing standards and procedures.
  • Review of documentation and production records to ensure all product is produced in compliance with QSRs and ISO standards and ensure all Device History Records (DHR) are complete, accurate and compliant to Good Documentation Practice (GDP).
  • Review and update device Validation Master Plan (VMP)
  • Creation and approval of test protocols and reports in support of equipment qualifications (IQ/OQ/PQ), design verification, continuous improvement projects, validation activities and Gage R&R studies.
  • Creation and review of technical reports and documentation.
  • Support or lead root cause analysis investigations for production-related or quality-related nonconformities (respectively) and develop and aid in the implementation corrective actions.
  • Development and implementation of effective corrections/corrective actions.
  • Partner with R&D and Manufacturing Engineers to develop/refine critical manufacturing processes.
  • Function as a core-team member in cross-functional teams in the generation and implementation of improvement projects and process scale-up projects.
  • Audit the manufacturing line to ensure compliance to governing procedures is being met.
  • Support Internal and External (supplier) audits.
  • Support elements of the Quality System such as, but not limited to, NCRs, CAPAs and Complaints.
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