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QA Compliance Engineer

QA Compliance Engineer

Job ID 
2017-1013
Job Locations 
US-MA-Chelmsford
Category 
Quality, Regulatory Affairs, and Service
Type 
Full-Time/Regular

More information about this job

Overview

This individual will drive Quality Improvements through the Corrective and Preventative Action program in a cross functional environment. Support the Organizations Internal Audit program and participate in external audits to ensure we maintain regulatory compliance. Assist with content review for Quality System documents and regulatory communication.

This position reports to the Director of Quality Control and Quality System Compliance

Responsibilities

  • Review CAPA(s) for appropriate content Monitor and Manage CAPA KPl(s) to objectives
  • Ability to lead a cross-functional team through CAPA
  • Maintain and look for opportunities to continuously improve the CAPA process and compliance to all applicable regulations
  • Conduct appraisals program yearly or as needed for CAPA Leads Assist in the development, training and expectation for CAPA Leads Assist in the management and scheduling for Internal Auditing Ensure internal audit finding response time meets internal targets Ensure timely closure of internal audit responses
  • Participate in external audits related to manufacturing site under QMS umbrella Ensure timely QS compliance related to SOP review
  • Assist in the review of Health Risk Assessment's
  • Assist in the development and review of Competent Authority, Registrar and Regulatory Agency correspondence

Qualifications

  • Minimum 5 years related experience in a regulated environment, preferably Medical Device Industry
  • Excellent written, verbal and interpersonal communication skills Proficient time management and project management skills
  • Experience with ISO 9001, ISO 13485, 1SO14971 and FDA QSR for Medical Devices Proficient with auditing techniques

Education:

  • Four year degree