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Sr Quality Engineer

2 months ago

Irvine, United States Ledgent Technology Full time

Roth Staffing is looking for an Senior Engineer for our client (medical technologies firm) in Irvine, CA.

Summary:

This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of company' 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.

Core Responsibilities:

  • Work with new product development teams (Implants, Delivery Systems and/or Accessories) to help them efficiently navigate the company' 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

Required Education & Experience:

  • Bachelor's degree in engineering required.
  • 5-7 years experience required.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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