Quality Engineer lll

Company: Staffing Future Inc.
Location: Pleasanton
Posted on: May 28, 2023

Job Description:

Quality Engineer lll
Pleasanton, California

Position - Quality Engineer lll
Location- Pleasanton, CA
Duration: - 12 Month
Overview

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• This role is responsible for quality support for manufacturing, servicing, and warehousing of manufactured products. The Quality Engineer III will coach manufacturing quality personnel on GMP and SOP compliance and empower them to identify and escalate quality issues, to ensure overall quality of the product. This position is for a Coolsculpting (medical device) site located in Pleasanton, California.
  
  Major Duties
  
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  • Participate in design reviews, Risk Management, Validation & Verification plans and reports during Product Development as required.
    
  • Responsible for Design Transfer activities for new product introductions internally or externally, ensuring quality and manufacturing process readiness. Support and/or drive Equipment and Process Validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (OQ), internally or externally.
    
  • Development of Master Validation Plan, Quality Plans and Reports
    
  • Provide quality inputs and/or requirements as applicable.
    
  • Focuses and determines proper engineering principles on reliability issues.
    
  • Drive and own quality assurance and requirements during development phases and post-market release, including Change Control
    
  • Implement lessons learned in other/new products, respectively new or running projects.
    
  • Identify and manage Critical to Quality (CTQ's)
    
  • Adhere to defined and communicated Corporate Quality requirements, applicable Regulatory Standards, methods, and procedures, with openness to identifying improvements.
    Focus on streamlining activities for increased efficiencies.
    
  • Control of Documentations
    
    Education
    
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    • Bachelor's degree in engineering (mechanical, industrial, chemical, electrical), or other technical discipline, or advanced degree in other disciplines, or equivalent experience preferred
      
    • Demonstrated competency with desired 8+ years of quality engineering and/or operations experience including a minimum 5 years' experience in an electro-mechanical, assembly and test manufacturing environment.
      
    • Proficiency in reading and interpreting mechanical drawings and GD&T.
      
    • Medical Device Auditor certification preferred.
      
    • Certified Six Sigma Black Belt, Green Belt or Lean Master preferred with proven completion of projects in which solutions were sought at the root level of the problem
      
      
      Why Kelly?
      As a Kelly employee, you'll have access to world-class perks, including:
      
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      • Kelly-sponsored Affordable Care Act health care coverage available to eligible employees
        
      • Group insurance options
        
      • Service bonus plan
        
      • Holiday pay plan
        
      • Weekly electronic pay options
        
      • Online training campus that provides more than 3,000 free courses to help improve and develop skills
        
      • Exclusive online employee community
        
      • Employee assistance program available at no cost
        
      • Corporate discounts
        
        Important information:This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
        
        8923441
        
        

Keywords: Staffing Future Inc., Pleasanton , Quality Engineer lll, Engineering , Pleasanton, California