Space Designation: Onsite = dedicated workspace & at least 80% onsite
Summary
Job Description
This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Edwards Global Supply Chain.
This Cross Functional Partner Will
interact with various functional departments to accomplish compliance and implementation of quality goals within Pilot Manufacturing,
work with new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies and
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/Experience
Bachelor's degree in engineering required.
5-7 years experience required.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Engineering and Information Technology
Industries
Staffing and Recruiting
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