QA Compliance Specialist in Huntington, WV at Apex Life Sciences

Date Posted: 6/4/2018

Job Snapshot

Job Description


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

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.