Quality Engineer - Santa Clara California

Company: Spectraforce Technologies
Location: Santa Clara, California
Posted On: 01/26/2025

Job Title: Quality Engineer IV
Duration: 12 Months
Work Location: Santa Clara, CA, 95054
Shift timing: 8am - 5pm

Job Description:

• Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan software development procedures and industry regulations.
  
• They support their RA organization and their business unit from a quality and compliance perspective.
  
• Looking for someone with quality systems experience who has senior level expertise.
  Activities they do is supporting audits for RA manage all CAPA's for RA organization.
  
• Key task for this role is putting together a KPI dashboard maintaining that from a compliance perspective to keep a pule on metrics that they have.
  
• Highlight risks if they see them and put in mitigation plans before they become audit findings or nonconforming results in CAPA related activities.
  
• Supports management and creation of the processes that allows the RA specialist to execute those submission requirements.
  
• Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis.
  
• Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs.
  
• Occasionally provide training for select software development activities for LifeScan.
  
• Occasionally write and execute test protocols and reports. 7+ years
  
  Soft skills
  
  
  
  
  • Independent good clear communication skills, team player, there will be a lot of international cross function interactions.
    
  • Good project management skills.
    
  • Problem solving expertise.
    
    Education:
    Bachelors Degree
    Experience:
    7+ years of experience More...

        

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