Trinus Corporation 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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