Director Quality Assurance

Director Quality Assurance

 

The Company

Our client is a privately owned world leader in the design and manufacture of miniature, ultra -high precision deep drawn tubular and flat stamped components. A Connecticut manufacturer certified to ISO 13485:2003 and ISO 9001:2008. Our client produces and ships medical device components worldwide. In this highly technological and dynamic industry they support their customers through ongoing collaboration to identify and transform ideas and requirements into a proven and effective product.

Position Summary

Maintain and continuously improve the quality management system (QMS) and perform other Quality assurance tasks to maintain the company’s compliance to FDA Quality System Regulation, ISO 9001 and ISO 13485. Work closely with all staff to ensure that all aspects of the QMS is understood, implemented and maintained. Be the cheerleader for quality in the company. Other quality positions may report to this position.

 
Position: Director Quality Assurance
Status: CLOSED

Key Responsibilities

  • Act as the QMS management Representative
  • Chair the Management Review meetings
  • Maintain the Quality Management System to ISO 13485 and other applicable requirements
  • Assure that the corrective and preventative action program is effective
  • Provide Quality Planning for products, verifications and validations
  • Develop metrics to measure quality of products and efficiency of the QMS
  • Assist in supplier qualifications, maintain the supplier files, assure supplier reevaluations, and perform vendor audits, where necessary
  • Manage an internal auditing program
  • Provide QA system training
  • Manage the gage control and calibration programs
  • Monitor/Audit Design Control Process
  • Assure proper maintenance of Quality Records
  • Monitor the regulatory environment for changing Quality policies, processes and procedures
  • Manage Receiving Inspection
  • Assure an effective incoming inspection process
  • Set annual quality goals
  • Review product release processes
  • Oversee the Document Control System
 

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