Quality Engineering

• Performs quality processes including change control, supplier non-conformance, quality agreements.
  
• Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives. Lead supplier quality evaluations. Provide third party inspection support.
  
• Lead defect resolution, root cause investigation, and continuous improvement activities. Collaborate across functions to confirm if non-conformances are supplier related as applicable.
  
• Support internal and/or external cross-functional and cross sector project teams driving supplier improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability.
  
• Provide Quality Engineering support to suppliers including verification/validation activities. Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Three Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes related to raw materials, services, and finished products.
  
• Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems.
  
• Support alignment with enterprise standards and executing gap assessments.
  
• Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas: Supplier Quality procedures, medical devices, and combination products.
  
• Evaluate processes to determine if refinements would enhance speed of results and productivity.
  
• Share ideas on how results can be achieved more quickly.
  
• Examine the quality of products and customer service.
  
• Identify steps to improve in these areas.
  
• Build & reinforce a sense of urgency on key projects; help others understand the criticality of these efforts.
  
• Listens and responds effectively, seeks clear requirements, and follows up in a timely manner.
  
  

Requirements

• Bachelor s degree is required, preferably in an Engineering, Life Science, or related discipline.
  
• 5 years of experience as a professional in a regulated industry, preferred Medical Device.
  
• Basic understanding of the Medical Device Quality Systems, emphases on purchasing controls.
  
• Require working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending.
  
• FDA and ISO regulations knowledge. 21 CFR 820; 21 CFR 210/211; ISO 13485; ISO 9001; Canadian CMDCAS; Japanese PAL; Anvisa Australian TGA is preferred.