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Senior Quality Engineer

1 month ago

Irvine, United States Intellectt Inc Full time

The main function of a Quality Engineer is to apply engineering theory and principles to quality issues and ensure compliance to standard procedures and regulations.


Key Responsibilities:

  1. Manage end to end CAPA process with the support of SMEs from a cross functional team. Work with the CAPA owners and lead investigations of complex manufacturing product quality and compliance issues (e.g., CAPA, audit observations) for all production processes based on engineering principles. Perform robust root cause analysis investigation, develop, and implement corrective actions, and establish effectiveness monitoring plans.
  2. Manage all phases of the CAPA process for specific events, including documentation, root cause analysis investigation, record management, and assembly of robust CAPA files within the CAPA Management System.
  3. Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures.
  4. Quality Systems Engineering support, including Post-Market Quality Engineering support
  5. Guide others in resolving basic issues in specialized area based on existing solutions and procedures.
  6. Train, coach, and guide employees on CAPA procedures.
  7. Other incidental duties assigned by Leadership.


Education and Experience:

  1. Bachelor’s Degree in Engineering or related field plus 4 years relative regulated industry experience required; Electrical Engineering degree preferred.
  2. Master’s Degree will offset one (1) year of required experience.
  3. Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
  4. Hands on engineering experience with electronics preferred
  5. ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications preferred.