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Quality Assurance Specialist II GEJP

Eingestellt von Software Specialists

Projektbeschreibung

LOCATION: FLORENCE, SC
DURATION: 02 MONTHS
TITLE: QA (CAPA)

KEY RESPONSIBILITIES INCLUDE:
* Leading CAPA activities including coordination/management of overall CA/PA system, CAPA Impact Analyses, and Product Field Action Coordination and execution
* Ensuring regulatory compliance and optimization of quality system procedures relating to CAPA, complaint handling, adverse event reporting and product field actions through development, maintenance and improvement of documented processes, development and implementation of employee training, and development and implementation of quality metrics to drive improvement and business results
* Leading/Supporting key QA/RA activities as assigned including CAPA investigations, Training, and Internal Auditing
* Identify and report any quality or compliance concerns and take immediate corrective action as required

QUALIFICATIONS (MUST HAVES):
* Bachelor's degree or Associate's degree (or high school diploma/GED plus 4 years of related work experience).
* Minimum of 3 years experience in a medical device or pharmaceutical industry.
* Minimum of 3 years experience with CAPA systems, including complaint handling.
* Minimum of 3 years experience applying regulations (including FDA QSR, ISO13485).
* Ability to communicate effectively (both written and oral) in English.

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Software Specialists

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