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Senior Quality Engineer

Irvine, CA 92614

Posted: 10/25/2023 Employment Type: Contract Job Category: Engineering Job Number: 585748 Is job remote?: No Country: United States

Job Description


The Supplier Quality Engineer is a key role of an innovative and challenging project within Transcatheter Mitral and Tricuspid Therapies (TMTT). This is a cross-functional position in partnership with the Quality, R&D, and Operations with a primary focus to lead in the development, improvement, maintenance, and management of suppliers. The Senior Quality Engineer will work on-site in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.

Responsibilities:
  • Lead part and supplier qualification activities in compliance with Client Quality Management System requirements
  • Support component specification development, identification of critical features, development of inspection methods and plans, test method validation, and component capability assessments
  • Lead risk management activities, including the development and implementation of FMEAs, process control plans, and quality agreements at suppliers.
  • Support suppliers in the development, approval and execution of process validation protocols and reports for critical processes
  • Perform audits of Quality Systems and Processes at suppliers of materials, components, sub-assemblies, and services.
  • Analyze and support the effective resolution of complex manufacturing and compliance issues at suppliers resulting from audit observations, incoming/process non-conformance reports, and customer complaints
  • Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities.
  • Collect and analyze Quality metrics relating to Supplier Quality

Preferred Qualifications
  • Demonstrated engineering experience in Supplier Quality, Supplier Development, New Product Development, or Manufacturing Engineering in medical device or other regulated industry.
  • Knowledge of complex catheter and implant manufacturing preferred
  • Thorough understanding of risk management principles and techniques
  • Experience with the use of statistical techniques, Six Sigma tools, and DMAIC problem solving techniques.
  • Strong problem solving and critical thinking skills.
  • Ability to work independently without close supervision.
  • Ability to manage competing priorities in a fast-paced environment.
  • Possess the ability to multi-task, while maintaining high attention to detail
  • Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)
  • Knowledge and understanding of FDAs 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards preferred.
  • ASQ Certified Quality Manager, Quality Engineer, Quality Systems Lead Auditor or related quality or regulatory certifications a plus.

Education/Experience:
  • Bachelor's degree in engineering required.
  • 5-7 years experience required.
50-59 pay rate range
**salary will be commensurate with experience**

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.