CAPA Process Analyst II
Posted on: September 24, 2022
Experis, a ManpowerGroup company, has an exciting contract
opportunity with one of our key clients, a global medical devices
and health care company that is engaged in the discovery,
development, and manufacturer of medical equipment and healthcare
products. Job Title: CAPA Process Analyst IILocation: Princeton,
NJ.Duration: 06 months (with possible extension)Shift 1 st - 08:00
AM- 05:00 PM CAPA Process Analyst:
- Progresses investigations and other activities through the CAPA
- Leads cross-functional teams in the use of investigational
tools to determine the root cause of nonconformities, ensures that
CAPA plans address root causes and that CA/PAs are implemented
timely to facilitate the rapid and compliant introduction of
new/improved products, processes, and systems.
- Ensures that actions are on time, thorough, complete, and meet
the needs of the business and customers, and that required
standards and/or procedural requirements are met.
- Leads a multifunctional team, ensuring that all communications,
interpersonal interactions, and business behaviors are consistent
with the Client's Code of Conduct.Main Responsibilities:
- Leads the investigation of complex and highly technical quality
issues to ensure the timely completion of CAPA system activities
raised for nonconformances, potential nonconformances, CAPAs,
deviations, and/or complaint investigations.
- Is a subject matter expert on investigation and root cause
analysis techniques to ensure that root/potential causes are
appropriate and implement effective actions to reduce the
occurrence/recurrence of the nonconformance.
- Maintains the effectiveness of the CAPA system records to
ensure audit-readiness for internal and external quality system
audits within the area.
- Ensures all CAPA-related documentation is managed in a
complete, clear, concise, and controlled manner.
- Produces trending metrics and reports to identify, prioritize
and manage further actions, as may be required.
- Provides leadership for the initiation of improvement
activities associated with identified trends.
- Is an active leader supporting a work environment that ensures
team effectiveness by demonstrating full cross functional team
support that complies with Corporate and regulatory
- Ensures effective written and verbal communications.
- Prioritizes workload in relation to the needs of the
- Supports the attainment of Client's Point of Care goals and
- Knowledge of the Corrective and Preventative Action process in
- Understanding of statistics
- Experience with medical devices
- Bachelor of Science in a life science or engineering discipline
Keywords: Experis, Trenton , CAPA Process Analyst II, Professions , Princeton, New Jersey
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