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Sr Engr

Irvine, CA 92614

Posted: 03/08/2024 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).

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Irvine, CA

Take the next step in your career journey in the vibrant city of Irvine, California! Nestled in the heart of Orange County, this thriving community offers unparalleled growth opportunities and an unbeatable quality of life. With its close proximity to stunning beaches, world-class shopping at South Coast Plaza, a bustling culinary scene featuring diverse cuisine options, and cultural attractions like the Irvine Museum and Irvine Barclay Theatre, Irvine has something for everyone. Whether you're into outdoor activities in Irvine Regional Park or catching a game at the Angel Stadium of Anaheim or the Honda Center, this region has it all. Explore our job listings today and discover why Irvine is the perfect place to advance your career!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.