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Quality engineer

Lorven Technologies Inc

Hi ,


Our client is looking for an Quality engineer for Reedsville, PA (Day 1 Onsite) a project and below is the detailed requirement.


Job Title: Quality engineer

Location: Reedsville, PA (Day 1 Onsite)

Duration: Long Term Contract and Fulltime


Responsibilities:

  • Bachelor's degree in Computer Science, Information Systems, Business, or a related field.
  • Must have a CAPA Lifecycle Management.
  • You should have a Nonconformance and Deviation Management.
  • Must have a Root Cause Analysis Techniques.
  • Good Experience in 8+ years of Medical Device Quality Systems experience.
  • You should have a Minimum 3 years of CAPA management experience.
  • Strong Experience supporting regulatory audits and inspections.
  • Good Experience in eQMS and Quality Metrics Reporting.
  • Must have a FDA 21 CFR Part 820, ISO 13485, ISO 14971.
  • Good Experience to Manage CAPA lifecycle from initiation to closure.
  • Must Monitor CAPA timelines, aging, and effectiveness.
  • You should Facilitate CAPA review meetings and follow-ups.
  • Must Review CAPA documentation for compliance.
  • Good Experience to Support audit and inspection readiness activities.
Vacancy posted 4 days ago
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