Senior Quality Engineer

Company: Veterans Prime, Inc.
Location: Germantown
Posted on: March 19, 2023

Job Description:

Overview
We are looking for a Senior Quality Engineer located in Germantown, WI. The Senior Quality Engineer will monitor and continuously improve upon the Quality System Elements.
Qualifications
A qualified candidate would fulfill these requirements:

• 
  
• Bachelor's degree in a science/engineering related field and seven to ten years of experience, or combination of accrued on-the-job experience and training.
  
• QS / ISO System experience.
  
• Understanding/working knowledge of ISO13485, ISO 16949 and FDA 21 CFR Part 820 and 11.
  
• Previous auditing experience is preferred.
  
• Experience with ISO class 8 cleanroom is desirable.
  
  Responsibilities
  Below are the essential duties and responsibilities:
  
  • 
    
  • Perform batch record review to release products.
    
  • Develop, review and approve validation protocols and final reports. Analyze the validation data. Assist in deviation resolution and corrective actions.
    
  • Facilitate audit finding and complaint investigation meeting.
    
  • Review and approve complaint, CAR and exception report.
    
  • Act as a liaison between customer and company.
    
  • Act as subject matter experts on quality system processes.
    
  • Assist in development of control plan, PFMEA, visual criteria, manufacturing work instruction, incoming inspection plan and in process inspection report for new products.
    
  • Provide disposition of nonconforming products.
    
  • Review and approve engineering change package.
    
  • Update manufacturing related procedures and quality system procedures to address gaps.
    
  • Mentor QEs in their daily tasks.
    
  • Continuously improve the quality system.
    
  • Acts as backup for the quality manager during 2nd and 3rd party audits.
    
  • Perform internal audit.
    
  • Other duties as assigned.
    

Keywords: Veterans Prime, Inc., Milwaukee , Senior Quality Engineer, Engineering , Germantown, Wisconsin