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Sr Quality Systems Specialist

  • Location: Fort Worth, TX
  • Salary:
  • Posted: Nov 14

Click here to view a full job description and apply if qualified!


As a Sr. Quality Systems Specialist you will provide guidance to other functional departments in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
Come for a job, stay for a career.
A Day in the Life
In this exciting role you will:
• Assists in the support of performance of liaison activities between the company, various governmental agencies and the Notified Body.
• Participates in the planning and execution of internal Quality System monitoring/audit activities to ensure continuing compliance with domestic and international medical device manufacturing regulations, internal company SOPs, ISO 13485 quality standards, corporate policies and guidelines.
• Demonstrates strong technical proficiency in the application of the Corrective and Preventive Action system, to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources.
• Demonstrates proficiency in translating quality requirements and initiatives into specific objectives, action plans, and metrics.
• Responsible for entering and maintaining data within the CAPA database, providing routine status reports and updates to current CAPA system activities.
• Works closely with personnel from surrounding functional groups, including, but not limited to Quality Engineering, Supplier Quality, R&D Engineering, Manufacturing, Marketing and Purchasing as necessary to provide assistance/guidance needed in managing quality system activities related to their functional areas. In addition to CAPA activities, this includes documentation of inputs and responses to protocols and reports, completion of Change Orders, preparation of CAPA Data presentations and Metrics reports.  
Must Have: Minimum Requirements

Click here to view a full job description and apply if qualified!

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