Ian Stetkiewicz
Senior Development Quality Engineer at Medtronic
- Role
- Senior Development Quality Engineer at Medtronic
- Location
- Boston, MA, US
- LinkedIn followers
- 500 followers
About Ian Stetkiewicz
Experienced Analysis Engineer with a demonstrated history of working in the medical device industry. Skilled in Medical Devices, SolidWorks, and Teamwork. Strong engineering professional with a Bachelor\'s of Science focused in Mechanical Engineering from University of Maryland - A. James Clark School of Engineering. Passionate about working with and creating products for people struggling with disease in order to better the quality and longevity of life of the affected individuals.
Experience
Senior Development Quality Engineer
Nov 2023 — Present · Danvers, MA, US
Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product• Collaborate with engineering and manufacturing functions to ensure quality standards are in place• Perform risk assessment activities to identify product quality or compliance risks and lead efforts to mitigate those risks• Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment• Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications• Implement approved changes using sound quality engineering principles and fully document them in compliance with Quality System Regulation (QSR 21 CFR 820), ISO 13485:2003• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
Education
University of Maryland - A. James Clark School of Engineering
Bachelor's of Science, Mechanical Engineering
2013 — 2017
Skills
- Microsoft Office
- Powerpoint
- Microsoft Excel
- Leadership
- Mechanical Engineering
- Customer Service
- Microsoft Word
- Research
- Teamwork
- Medical Devices
- Autodesk Inventor
- Creo Parametric
- Solidworks
- Engineering
- Time Management
- Autocad
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