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Quality Engineer

Irvine, CA 92614

Posted: 05/30/2024 Employment Type: Contract Job Category: Engineering Job Number: 607768 Is job remote?: No Country: United States

Job Description

Target PR Range: 48-58/hr
*Depending on experience

Summary:
This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of 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 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 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.
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