Skip to content

Job Openings

Senior Quality Engineer

Irvine, CA 92614

Posted: 09/20/2023 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.

  • 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.

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

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

Although this hasn't been an issue at The Planet Group, 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 The Planet Group.

Wordpress Social Share Plugin powered by Ultimatelysocial