Post Market Quality Supervisor

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Position Summary

Maintains the Corrective and Preventive Action (CAPA) and Non-Conforming Product Systems . Responsible for overseeing and direction of the 1 Quality System Coordinator .

Primary Responsibilities / Essential Functions

• Directs activities to resolve all internal/external complaints . This will be done by providing appropriate documentation , risk assessment, routing , corrective and preventive action evaluations, letter preparation, problem solving assistance and FMEA assessments.
• Works with the Quality System Coordinator to ensure they have the necessary support or backup related to the functions of that position.
• Participates in Customer audits and ISO registrar QMS audits and provides support for resolving resulting action items .
• Provides assistance to teams in resolving quality corrective actions.
• Prepares quality alerts , customer information or any relevant information for posting in the production area . Directs activities to ensure this information is routinely rotated and other postings are included to maintain interest .
• Actively engages with other departments to support complaint investigations ; lead investigations , observ e production activities, interview Subject Matter Experts, etc.
• Provides back up functions for the Quality Manager when requested .
  
  

SUPERVISORY RESPONSIBILITIES: (location specific)

• Manages one employee in th is segment of the Quality Department . R esponsible for the overall direction, coordination, and evaluation of this segment . Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws . Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
  
  

Basic Qualifications

Education and/or Experience

• Bachelor’s degree or four years related experience and/or training; or equivalent combination of education and experience.
  
  

Preferred Qualifications

• Strong PC skills, including knowledge and application of spreadsheet, word processing and graphical analysis software is highly desired.
• Some background in Total Quality Management (TQM), FDA Good Manufacturing Practice (GMP), and ISO 13485 concepts is desired.
  
  

Working Conditions

• Prolonged periods of sitting at a desk and working on a computer .
• Must be comfortable engaging within a production environment.
• Must be able to lift up to 10lbs.