Quality Engineer, Medical Devices, THV Transcatheter Heart Valve

Job Description: This Quality Engineer will support the Pilot Quality Engineering team for the Transcatheter Heart Valve (THV) Business Unit as a part of Edwards Global Supply Chain. This cross functional partner will (1) interact with various functional departments to accomplish compliance and implementation of quality goals within Pilot Manufacturing, (2) work with THV new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies and (3) support product transfer from Pilot Manufacturing to receiving site manufacturing facilities.

Key Responsibilities

• Work with new product development teams (Implants, Delivery Systems and/or Accessories) to help them efficiently navigate the Edwards' Quality System in order to build quality system test samples and human use product according to project schedules
• Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes
• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
• Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop/drive improvements for inspection test methods
• Lead test method validation activities for in-process inspections
• Facilitate and oversee Material Review Board to disposition potentially non-conforming human use products
• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements
  
  

Education And Experience

• Prior experience in medical device manufacturing or operations preferred
• Bachelor's Degree in relative Engineering field plus minimum of two (2) years medical device industry experience preferred
• Master's Degree in relative Engineering field plus minimum of one (1) years medical device industry experience preferred
• Ph.D. in Engineering field with relative thesis, post doctorate research or technical engineering rotation experience preferred
  
  

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