Engineering - Sr Engr

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 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.
Additional Sills: Skills: No items to display.

Trinus Corporation, a leading provider of technology solutions and services with over 25 years of experience, is a certified WBE/MBE/SBE/SDB firm accredited by WBENC, NMSDC, and SBA. Our mission is to shape the future of work by aligning the right mix of people, process, technology, and innovation to efficiently meet our clients' business objectives. At Trinus, we understand that finding the right opportunity is pivotal in your career journey. Our staffing services go beyond mere placements; they are about matching your skills and aspirations with the perfect fit. To learn more about us, please visit our website