Senior Quality Engineer
17011 Red Hill Avenue Irvine, CA 92614 US
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
- 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.
**salary will be commensurate with experience**
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