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Sr Engr

Irvine, CA 92614

Posted: 02/12/2024 Employment Type: Contract Job Category: Engineering Job Number: 600235 Is job remote?: No Country: United States

Job Description


Target PR Range: 49-59/hr
*Depending on experience 

Summary:

The Senior Quality Engineer will focus on providing ownership and support of all phases of the CAPA process including investigations, robust root cause analysis, development and implementation of corrective actions, and effectiveness monitoring and will interact with the CC global manufacturing sites. Job Responsibilities:
  • Manage end to end CAPA process with the support of SMEs from a cross functional team. 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.
  • 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.
  • Apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures.
  • Quality Systems Engineering support, including Post-Market Quality Engineering support.
  • Guide others in resolving basic issues in specialized area based on existing solutions and procedures.
  • Train, coach, and guide employees on CAPA procedures.
  • Other incidental duties assigned by Leadership.

Skills:
  • Professional level proficiency with MS Office Suite (Outlook, Word, Excel, Power Point, MS Project)
  • Extensive knowledge and understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering.
  • Working knowledge and understanding of statistical techniques.
  • Ability to read and interpret drawings.
  • Strong leadership skills and ability to influence change.
  • Ability to prioritize, plan & evaluate deliverables to established strategic goals.
  • Proficient knowledge of Quality Engineering concepts relative to the level of role (Senior Engineer)
  • Must be able to work in a collaborative team environment, including inter-departmental teams and key contact for internal and outside customers.

Education/Experience:
  • Bachelor's degree in engineering required.
  • 5-7 years experience required.
  • Working knowledge of the Domestic and International regulatory Medical Device regulations (FDA 21 CFR 820, ISO 13485; and other applicable regulatory requirements).
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