QA Compliance Specialist - CAPA, risk assessment in Huntington, WV at Apex Life Sciences

Date Posted: 5/16/2018

Job Snapshot

Job Description


The role of the QA Compliance Specialist is to execute and monitor all Quality Systems to include Quality Manual implementation, CAPA effectiveness, audit support (external and internal), metrics/KPI reporting, Quality Plan implementation, management review, and Quality Risk Assessment (QRA) programs.  
    
Responsibilities:

  • Support implementation of Regulatory Authority, internal Divisional Quality System requirements through gap assessment activities.
  • Generation and collection of system metrics and measurements to support the ongoing maintenance of site compliance.  Collaborate with Divisional Quality System and Compliance groups to ensure consistent metric reporting across Surgical business unit. 
  • Collection, preparation, and presentation of Compliance data and trend reports for Quality Management Reviews.  Compilation of Quality Management Review minutes and final report, and oversight of follow-up activities.
  • Execution and monitoring of Site Quality Plan objectives. 
  • Champion continuous Quality System improvement and effectiveness.  Maintain a detailed knowledge of the Medical Device regulations, guidance and requirements. Promote awareness of best industry practices, providing company training as required.
  • Participate in audit readiness and execution activities as required.  Monitoring of audit follow-up activities.

Requirements:

  • Bachelor of Science Degree in science-related field, preferred.
  • Excellent knowledge of English and proficient in Site local language.
  • 1-3 years applicable experience with preference in Compliance, Medical Device QA or related field.  
  • Ability to sets clear direction & aligns team & Others  Around Common Objectives
  • Must be able to energizes the team
  • should display passion for the 3Cs
  • Exercises good judgement & drives change for competitive advantage
  • Must also drive for superior results & has passion to win
  • Ability to inspires continuous improvement & breakthrough thinking
  • Displays Analytical & Conceptual thinking