1+ months
2018-06-222018-08-22

Quality Manager

American Society of Civil Engineers
MA

Overview:

The Quality Manager is responsible for the development, deployment and maintenance of our cGMP/ISO 9001:2015 Quality Management System and Hazardous Communications Program. This Position requires working closely with the President and Vice President to administer and maintain these systems. Experience with chemical analysis and a demonstrated working knowledge of FDA, ISO and international medical device regulations is highly desired.  This is a “hands-on” position in the daily operations of the QMS.

 

Job responsibilities:

  • Establish and maintain day to day operations of the QMS (ISO 9001:2015, FDA 21 CFR 820, CFR 210, CFR 211) and Safety programs
  • Apply knowledge in regulations and external standards to guide and coach process owners in the development of compliant processes and procedures.
  • Monitor cGMP/cGLP studies to assure compliance with regulations and review final reports
  • Creation, revision control, retrieval, approval routing, and distribution for all standard operating procedures, and company policies in accordance with Document Control requirements
  • Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s services and products
  • Responsible for accuracy and timely inspection/calibration of all monitoring and measuring devices
  • Administer CAPA and deviation investigations, customer complaints, and non-conformances.
  • Conduct annual management review, internal audits and host customer audits
  • Maintain day to day operations of the Hazardous Communications Program
  • Responsible for maintain the integrity of the training system, including the oversight and development of training curriculums and programs
  • Any other duties as directed
  • Researching sources for services and products
  • Any other duties as directed

Minimum education/job experience: (where possible list equivalent experience for educational requirements)

  • Bachelors degree in Chemistry or Related Scientific Field preferred or related work experience
  • Demonstrated understanding of the relevant regulations, standards ISO 9001:2015, FDA 21 CFR 820, CFR 210, CFR 211 is required
  • 10+ year’s industry experience with demonstrated knowledge of Quality Management systems is preferred.
  • 2+ years in a leadership role

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Quality Manager

American Society of Civil Engineers
MA

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American Society of Civil Engineers
MA
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