We are looking for a Senior Quality Engineer in Pilot Operations to contribute to the development of delivery systems for clinical manufacturing within the Transcatheter Heart Valve (THV) Business Unit. In this role, you will ensure compliance, enhance quality processes, and drive impactful product lifecycle decisions.
Job Type: Contractual W2 without benefits
Estimated Contract Duration: 6 - 12 months, possible extension
Job Location: Irvine, CA (92614)
Key Responsibilities:- Collaborate with new product development teams to navigate quality systems for feasibility studies, quality system test samples, and clinical studies.
- Optimize manufacturing and inspection processes to improve efficiency and compliance.
- Conduct risk assessments for early-stage product manufacturing.
- Address complex quality challenges, including CAPA, non-conformances, and audit observations.
- Develop and validate inspection test methods to enhance reliability.
- Lead test method validation and oversee Material Review Board to ensure product compliance.
- Monitor product yields and defect rates, utilizing data insights for process improvements.
Qualifications & Skills:- Bachelor's or Master's Degree in Engineering with 3-4 years of medical device industry experience.
- Strong understanding of FDA regulations, quality engineering principles, and statistical analysis.
- Proficiency in Manufacturing Execution Systems (MES) and Minitab preferred.
- Excellent problem-solving, leadership, and communication skills in a fast-paced environment.
Be part of a team revolutionizing transcatheter heart valve replacement technology, driving innovation to improve patient outcomes worldwide.
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 www.trinus.com