Trinus Hiring for Engineering – Sr Engr at Irvine, CA, United States Full Time

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 Edwards’s 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 s 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 s, 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 FDA’s 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.

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