2 Quality Engineer, Medical Devices, THV Transcatheter Heart Valve Jobs in Irvine, CA
Trinus Corporation is Hiring a Quality Engineer, Medical Devices, THV Transcatheter Heart Valve Near Irvine, CA
Key Responsibilities
- Work with new product development teams (Implants, Delivery Systems and/or Accessories) to help them efficiently navigate the Edwards' Quality System in order to build quality system test samples and human use product according to project schedules
- Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes
- Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
- Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
- Develop/drive improvements for inspection test methods
- Lead test method validation activities for in-process inspections
- Facilitate and oversee Material Review Board to disposition potentially non-conforming human use products
- Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements
- Prior experience in medical device manufacturing or operations preferred
- Bachelor's Degree in relative Engineering field plus minimum of two (2) years medical device industry experience preferred
- Master's Degree in relative Engineering field plus minimum of one (1) years medical device industry experience preferred
- Ph.D. in Engineering field with relative thesis, post doctorate research or technical engineering rotation experience preferred
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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
Job Summary
Full Time
IT Outsourcing & Consulting
$107k-126k (estimate)
05/30/2024
08/21/2024
trinus.com
ARCADIA, CA
25 - 50
1995
SANJAY KUCHERIA
$5M - $10M
IT Outsourcing & Consulting
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About Trinus Corporation
In the digital world, Trinus Corporation has managed to develop and offer solutions and consulting services in data management, data analytics, and data security. Trinus is an IT consulting firm that helps its clients manage, access, and analyze data. Since 1995, we have worked with companies of all sizes and across industries to deliver business-aligned solutions along operational, tactical and strategic dimensions for driving revenue growth and operational efficiency. Our focus lies in Data Integration, Data Migration, Data Quality, Master Data Management, Data Governance, Data Warehousing, ...Data Lakes, Reporting, Dashboards, Visualization, Analytics, IoT, AI, Machine Learning, Blockchain & IT Security.
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