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Quality Coordinator

Rate of Pay $15 per hour 

(MUST HAVE QUALITY EXPERIENCE, ESPECIALLY WITH CORRECTIVE ACTIONS)

1. PRIMARY PURPOSE:   Coordinator of all quality throughout the company.
 
2. ORGANIZATIONAL RELATIONSHIP:  Reports to the Quality Manager
 
3. RESPONSIBILITIES:  

  • Understand basics of QMS and ISO9001:2008, Medical Device and FDA 
  • Maintain Document Control for the QMS 
  • Maintain the Record Retention Log 
  • Assist with maintaining the Operations Manual and Procedures  
  • Calibrate equipment and manage current revisions of templates 
  • Customer Complaints and Corrective/Preventive Action Reports 
  • Control of any non-conforming material, (quarantine, and investigate, CAPA)
  • Create and maintain Device History Records [DHR] 
  • Create and maintain Article History Records [AHR] 
  • Create and maintain Work Instructions 
  • Perform QC Inspections of product  
  • Create/Submit (BOM’s) Bill of Materials to Purchasing 
  • Periodically inspect product throughout the warehouse 
  • Proformance Products batch sampling 
  • All other duties as deemed necessary

 
4.  SKILLS REQUIRED TO PERFORM JOB RESPONSIBILITIES: 

  • Ability to read and understand written and verbal job instructions and procedures 
  • Attention to detail and high level of accuracy 
  • Skill and proficiency in the use of personal computer software programs including word processing and spreadsheet applications 
  • High school diploma or equivalent  
  • 1-3 years quality related experience

 
5.  ESSENTIAL FUNCTIONS OF THE JOB: 

  • Communicating both orally and written with members of the organization, as well as external parties relating to quality issues 
  • Organize and prioritize daily duties 
  • Able to perform hands on and visual QC Inspections of all products 
  • Problem solving 
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