Medical Device CAPA SME

Newark, NJ

Industry: Med Job Number: 128697


Medical Device CAPA SME

Environment:  Our client is a large medical device manufacturer that develops a number of Class II & III Devices. They are currently in need of a CAPA SME, dealing with closing aging  CAPA’ s as well as  real-time CAPA’ s that will arise. Experience CAPA coaching will be a big plus. 

Responsibilities:  Perform CAPA Remediation per protocol to ensure adequate failure investigation and CAPA content.   The client already has a CAPA strategy in place and is need of someone to provide hands-on as well as Project Management experience at this point. This individual must have experience dealing with CAPA’ s open to close, as well technical experience in order to conduct failure mode investigations, and root cause analysis.  The client highly prefers candidates with experience in remediation, specifically consent decree environments for Medical Device.

Main Duties:
  • Perform CAPA Remediation per protocol per schedule.
  • Manage CAPA’ s open to close in conducting failure mode investigations, and root cause analysis.
  • Alert management of product quality & compliance issues for proper and timely escalation to CAPA.
  • Setting Verification & Validation Criteria
  • Ensures CAPA documentation and records are adequate and compliance with good documentation practices
  • Generate and process for approval extension to CAPA project timelines.
  • Publish CAPA status progress reports and highlights potential issues which may jeopardize target completion date(s).

  • CAPA: 5-8+  years
  • Medical Device: 5-8+ years
  • 21 CFR Part 820
  • Verification & Validation

  • Capa coaching experience

Job Type: Contract

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