Quality Engineer II

• Completes all required training.
  
• Uses quality tools to implement improvements including: process flowcharting Pareto analysis correlation and regression analysis significance tests design of experiments statistical process control gauge repeatability and reproducibility and trend analysis techniques.
  
• Acts as a customer liaison and processes customer quality complaints as applicable.
  
• Collects Analyzes and Presents data using statistical methodology
  
• Assists suppliers with the interpretation of quality requirements as applicable.
  
• Assists the development of essential QMS deliverables/Advanced Product Quality Planning (APQP) including but not limited to: complaint analysis risk analysis failure mode and effects analysis CAPA and process/equipment/software verification / validation
  
• Plans and/or conducts process and equipment validations and special validations including installation qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ).
  
• Interfaces with appropriate customer contacts to clarify customer requirements
  
• Determines machine and/or process capability through planning and/or executing Process Capability studies
  
• Develops inspection criteria that connect customer requirements and manufacturing processes that include identification of key characteristics associated sampling plans and required gauging.
  
• Conceives and/or Leads productivity improvements and/or Continuous improvement projects
  
• Monitors engineering production processes and products for adherence to internal and external requirements and practices.
  
• Participates in pre and postproduction launch reviews providing quality engineering support
  
• Performs quality reviews and internal audits; evaluates data and writes associated reports
  
• Recommends modifications to existing quality or production standards where applicable to achieve optimum quality within limits of equipment capability.
  
• Reviews and approves product/process and document change requests.
  
• Reviews drawings to evaluate quality requirements including: correct application of geometric dimensioning and tolerance proper use of process and material specifications and key characteristics for inspection plans and gauging techniques.
  
• Supports measuring and analyzing key metrics to monitor performance.
  
• Works with crossfunctional teams to solve production and quality problems.
  
• Reinforces safety expectations. Ensures safety operating practices are demonstrated. Reports issues/concerns to Supervisor.
  
• Support quality and compliance by adhering to all procedures work instructions and forms per the Quality Management Systems (QMS).
  

Requirements

• Bachelor of Science (B.S) Engineering (Required)
  

• 3 Years of Experience (Required)
  
• 3 Years of Experience in a Manufacturing Environment (Preferred)
  
• Experience in Medical Device Manufacturing (Preferred)
  

• Any Quality Certification (Preferred)
  

• Must be able to remain in a stationary position frequently.
  
• Must be able to move about the inside of the building occasionally.
  
• Must be able to move equipment around the building occasionally.
  
• Must be able to position oneself and move under/around/over equipment frequently.
  
• Must be able to communicate and exchange information with others frequently.
  
• Must be able to distinguish and detect information such as writing and defects frequently.
  

• Occasional Noise