Dan Lee
Quality Systems Manager @ SHINE Technologies. Quality Management, FDA Inspection
- Role
- Quality Systems Manager at SHINE Technologies
- Location
- Milwaukee, WI, US
- LinkedIn followers
- 500 followers
About Dan Lee
Quality assurance professional with a broad depth of knowledge and experience in the medical device and pharmaceutical industry. Experience in areas such as FDA, ISO, Design Controls, CAPA, Risk Management, Production and Process Controls, SDLC, New Product Development, Software Development, and Hardware Development. Direct experience working with FDA, including successful closure of a warning letter. Also experienced in Project Management, Leading Cross-Functional Teams, Manufacturing, Customer Service, and Repair Operations. Outgoing individual with a drive to continuously improve.
Experience
Quality Systems Manager
Dec 2025 — Present · US
Oversee the development and maintenance of GMP quality management systems, ensuring compliance with regulatory requirements. • Proactively identify quality risks and establish mitigation strategies to enhance operational efficiency. • Lead internal and external audits, ensuring adherence to quality agreements with SHINE customers. • Develop and manage the departmental budget, optimizing resource allocation for quality initiatives.
Education
Herzing University
Associates, Electrical and Electronics Engineering
1991 — 1993
Cardinal Stritch University
Masters (MBA), Business Adminisration
2011 — 2014
Lakeland University
BS, Business Administration
1995 — 2001
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