Sr. Quality Engineer

Company: Span-America
Location: Greenville
Posted on: March 14, 2023

Job Description:

BASIC FUNCTIONS:The role of the Senior Quality Engineer is to work with engineering, process, and manufacturing personnel to develop specifications, processes and procedures that will ensure our products meet or exceed our customers' expectations. Organizer all major components of the QMS including change control, process control, calibration and CAPA through feedback. Continuous improvement should be an output from the constant QMS PDCA feedback loop. Leads the Quality Inspectors in daily activities to support above functions.ACCOUNTABILITIES:

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• Responsible for supervision of QA Inspectors / Technicians (in-process and outgoing quality). This includes the review of associated records.
  
• Quality Assurance Inspectors:
  
• Performs inspections and tests for incoming, in-process, and finished products. Serves as authority for release of Class II Devices for further distribution. Performs complaint investigations and service on returned products. Maintains records, including files of device history records.
  
• Administrates internal audit and vendor approval.
  
• Assist with the coordination of activities relative to corrective and preventive action.
  
• Assist in maintaining QA files of quality records - document control.
  
• Performs routine audits of the preventive maintenance program and other internal audits as assigned.
  
• Responsible for assisting in the coordination and administration of Engineering Change Orders from engineering to manufacturing for both new products and changes to existing products.
  
• Assist in ensuring that all activities relative to the engineering change are performed, documented, and records maintained - regulatory requirements, process capability/control, quality plans, etc.
  
• Performs trend analysis for complaints and other quality indicators, including quality objectives.
  
• Responsible for the calibration program
  
• Set up proper instrumentation to measure and record variables and train employees on proper use of the instruments.
  
• Establish Process Control Plans
  
• Interface with product development, manufacturing, process, and quality personnel as well as with Span America sales and marketing to determine product quality specifications.
  
• Provide all necessary information concerning product parameters and inspection to production personnel
  
• Evaluate processes and ensure they are capable of consistently meeting specification requirements
  
• Define attributes and sets accept/reject parameters
  
• Assist in developing effective corrective actions to quality issues
  
• Assist with returned product investigations as needed to understand failure modes and actions required.
  
• Assist with handling customer complaints and service requests.
  
• Assist with various Regulatory Activities:
  
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  • Develop regulatory strategies for product development and launch of new products.
    
  • Ensure that US and other international regulatory requirements are incorporated as part of the development process.
    
  • Assist or lead the preparation and maintenance of moderate-complexity regulatory submissions while maintaining quality standards.
    
  • Prepare responses to standard questions and comments from regulatory agencies and ensure issues are addressed in a timely manner.
    
  • Understand regulatory processes, guidelines and guidance documents and what they mean to the organization and ensures that they are communicated through regulatory procedures.
    
  • Maintain facility and product registrations and licenses with various regulatory bodies.
    
  • Establish and maintain Technical Files as applicable.
    
  • Compile and maintain regulatory documentation databases or systems.
    
    
    
  • Establish an effective Statistical Process Control Program
    
  • Willing to travel to customers to resolve quality problems and build effective customer relationships
    
  • Hands on, action oriented, and pays attention to detail
    
  • Customer/client focused
    
  • Other duties as necessary
    Technical Competencies:
    System Management and/or Maintenance & Development:
    
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    • Ability to understand and utilize basic statistical analysis.
      
    • Ability to perform root cause analysis and corrective action.
      
    • Ability to understand and utilize fundamental gauge validation and calibration.
      
    • Demonstrate knowledge of product fitness for use that meet or exceed customer expectations.
      
    • Demonstrates thorough understanding of auditing systems.
      
    • Ability to work independently.
      
    • Demonstrates basic mechanical aptitude ability.
      
      Data Management:
      
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      • Ability to collect, organize, analyze and report information in a meaningful way.
        
        Quality Management Systems:
        
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        • Ability to develop and maintain processes that are ISO, MDSAP and FDA compliant.
          
        • Demonstrates ability to lead and manage projects.
          
        • Ability to train and develop internal auditors.
          
        • Ability to utilize failure mode and effects analysis.
          
        • Ability to identify, execute and measure improvement opportunities.
          
          Safety:
          
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          • Demonstrates ability to understand and actively participate in all company safety policies and procedures.
            
            Training:
            
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            • Ability to develop, deliver and measure training as required.
              
              PHYSICAL JOB REQUIREMENTS:
              General physical demands described here are representative of those that may be required to successfully perform the essential functions of the job.
              Individuals may sit or stand as needed. Position may require walking and/or climbing stairs periodically throughout the day, reaching above shoulder heights; below the waist, or lifting as required to file documents or store materials throughout the workday. May include lifting up to 25 pounds for files, boxes, etc. on occasion. Proper lifting techniques are required.
              Primary environment: ambient room temperatures, lighting and traditional office equipment as found in a typical office environment. The performance of this position may occasionally require exposure to the manufacturing areas where the use of personal protective equipment such as safety glasses with side shields and fully enclosed shoes (no open toe or heel) are required.
              EDUCATION/EXPERIENCE:
              
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              • Bachelor's degree in an engineering, health science or related field preferred.
                
              • 1+ years' experience as a Quality Engineer in the medical device industry.
                
              • If degree is not in Engineering or a Health Science field, 5+ years of Quality Engineer or Medical Device Regulatory experience required.
                
                Span-America, a division of Savaria, is an EO/AA Employer of Minorities/Females/Disabled/Protected Veterans

Keywords: Span-America, Greenville , Sr. Quality Engineer, Engineering , Greenville, South Carolina