Dan Lee

Dan Lee Email and Phone Number

Quality Assurance Manager @ Opportunities, Inc. | Quality Management, FDA Inspection @ Opportunities, Inc.
Dan Lee's Location
Watertown, Wisconsin, United States, United States
Dan Lee's Contact Details
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.

Dan Lee's Current Company Details
Opportunities, Inc.

Opportunities, Inc.

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Quality Assurance Manager @ Opportunities, Inc. | Quality Management, FDA Inspection
Dan Lee Work Experience Details
  • Opportunities, Inc.
    Quality Assurance Manager
    Opportunities, Inc. Dec 2024 - Present
    Fort Atkinson, Wi, Us
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  • Northstar Medical Radioisotopes, Llc
    Senior Manager - Quality Assurance
    Northstar Medical Radioisotopes, Llc Jun 2020 - Dec 2024
    Beloit, Wisconsin, Us
    Quality Management of Product Development and Operations for Instruments and Pharmaceuticals. Lead for process improvements in areas such as CAPA, Deviations, OOS, and Design Controls. FDA Inspection lead for all NorthStar sites. Responsible for Internal Audit program and Management Reviews. Manage the QA teams in Product Development, Operations and Document Control.
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  • Northstar Medical Radioisotopes, Llc
    Quality Manager - Product Development
    Northstar Medical Radioisotopes, Llc May 2019 - Jun 2020
    Beloit, Wisconsin, Us
    Managing the new product development Quality Team. NorthStar is bringing the source of Radioisotopes for use in Nuclear Medicine back to the US, and I will be working with the new product development teams to make sure all areas of compliance are fully addressed.
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  • Treymed Inc.
    Director Of Quality Assurance
    Treymed Inc. Feb 2015 - Apr 2019
    Sussex, Wi, Us
    Management of the Quality and Regulatory department, driving continuous improvement in the Quality Management System. Extensive experience working directly with the FDA, including successful clearing of a Warning Letter. Managing the internal and external audit program, including FDA inspections. Implementing a robust CAPA process to manage corrective actions and bring the QMS into full compliance with the Code of Federal Regulations and International Standards Organization.
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  • Ge Healthcare
    Quality Assurance Leader
    Ge Healthcare Sep 2007 - Dec 2014
    Chicago, Us
    New product introduction in the Diagnostic Cardiology IT segment.QA reviews of Design History Files.Management of product holds.Mangagement of product complaints and CAPA.
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  • Emageon
    Program Manager
    Emageon 1994 - 2007
    Us
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  • Camtronics Medical Systems
    Program Manager
    Camtronics Medical Systems 1994 - 2007
    Us
    I was in charge of managing program teams in the areas of both new product development and maintenace releases for medical devices that were both hardware and software based.
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Dan Lee Skills

Quality Assurance Medical Devices Cross Functional Team Leadership Process Improvement Quality System Fda Design Control Capa Iso 13485 Six Sigma Product Development Manufacturing Management Internal Audit Quality Management Validation Quality Auditing Software Documentation Leadership Engineering V&v Sdlc Troubleshooting Program Management Iso 14971 Iso Project Management Business Process Improvement Corrective And Preventive Action Databases Continuous Improvement Certified Internal Lead Auditor Certified Asq Csqe Asq Csqe Lean Manufacturing Root Cause Analysis Gmp Healthcare Information Technology R&d Integration Fmea Dmaic Testing Product Management Change Control Supplier Quality Quality Control 21 Cfr Part 11 Regulatory Affairs

Dan Lee Education Details

  • Cardinal Stritch University
    Cardinal Stritch University
    Business Adminisration
  • Lakeland University
    Lakeland University
    Business Administration
  • Herzing University
    Herzing University
    Electrical And Electronics Engineering

Frequently Asked Questions about Dan Lee

What company does Dan Lee work for?

Dan Lee works for Opportunities, Inc.

What is Dan Lee's role at the current company?

Dan Lee's current role is Quality Assurance Manager @ Opportunities, Inc. | Quality Management, FDA Inspection.

What is Dan Lee's email address?

Dan Lee's email address is da****@****hoo.com

What is Dan Lee's direct phone number?

Dan Lee's direct phone number is +192028*****

What schools did Dan Lee attend?

Dan Lee attended Cardinal Stritch University, Lakeland University, Herzing University.

What are some of Dan Lee's interests?

Dan Lee has interest in Children.

What skills is Dan Lee known for?

Dan Lee has skills like Quality Assurance, Medical Devices, Cross Functional Team Leadership, Process Improvement, Quality System, Fda, Design Control, Capa, Iso 13485, Six Sigma, Product Development, Manufacturing.

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