Quality Assurance Manager
Current
Dec 2024 - Present
AeroLeads people directory · profile
Dan Lee Email & Phone Number
Quality Assurance Manager @ Opportunities, Inc. | Quality Management, FDA Inspection
at
Opportunities, Inc.
1 work email found
@northstarnm.com
2 phones found area 920
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Quality Assurance Manager @ Opportunities, Inc. | Quality Management, FDA Inspection
Location
Watertown, Wisconsin, United States
Who is Dan Lee? Overview
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Quick answer
Dan Lee is listed as Quality Assurance Manager @ Opportunities, Inc. | Quality Management, FDA Inspection at Opportunities, Inc., based in Watertown, Wisconsin, United States. AeroLeads shows a work email signal at northstarnm.com, phone signal with area code 920, and a matched LinkedIn profile for Dan Lee.
Dan Lee previously worked as Quality Assurance Manager at Opportunities, Inc. and Senior Manager - Quality Assurance at Northstar Medical Radioisotopes, Llc. Dan Lee holds Masters (Mba), Business Adminisration from Cardinal Stritch University.
Company email context
Email format at Opportunities, Inc.
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{first_initial}{last}@northstarnm.com
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Profile bio
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.
Listed skills include Quality Assurance, Medical Devices, Cross Functional Team Leadership, Process Improvement, and 46 others.
Current workplace
Dan Lee's current company
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7 roles · 32 years
Dan Lee work experience
A career timeline built from the work history available for this profile.
Senior Manager - Quality Assurance
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.
Jun 2020 - Dec 2024
Quality Manager - Product Development
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.
May 2019 - Jun 2020
Director Of Quality Assurance
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.
Feb 2015 - Apr 2019
Quality Assurance Leader
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.
Sep 2007 - Dec 2014
Program Manager
1994 - 2007
~13 yrs
Program Manager
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.
1994 - 2007
~13 yrs
3 education records
Dan Lee education
Masters (Mba), Business Adminisration
Cardinal Stritch University
Bs, Business Administration
Lakeland University
Associates, Electrical And Electronics Engineering
Herzing University
FAQ
Frequently asked questions about Dan Lee
Quick answers generated from the profile data available on this page.
What company does Dan Lee work for?
Dan Lee works for Opportunities, Inc..
What is Dan Lee's role at Opportunities, Inc.?
Dan Lee is listed as Quality Assurance Manager @ Opportunities, Inc. | Quality Management, FDA Inspection at Opportunities, Inc..
What is Dan Lee's email address?
AeroLeads has found 1 work email signal at @northstarnm.com for Dan Lee at Opportunities, Inc..
What is Dan Lee's phone number?
AeroLeads has found 2 phone signal(s) with area code 920 for Dan Lee at Opportunities, Inc..
Where is Dan Lee based?
Dan Lee is based in Watertown, Wisconsin, United States while working with Opportunities, Inc..
What companies has Dan Lee worked for?
Dan Lee has worked for Opportunities, Inc., Northstar Medical Radioisotopes, Llc, Treymed Inc., Ge Healthcare, and Emageon.
How can I contact Dan Lee?
You can use AeroLeads to view verified contact signals for Dan Lee at Opportunities, Inc., including work email, phone, and LinkedIn data when available.
What schools did Dan Lee attend?
Dan Lee holds Masters (Mba), Business Adminisration from Cardinal Stritch University.
What skills is Dan Lee known for?
Dan Lee is listed with skills including Quality Assurance, Medical Devices, Cross Functional Team Leadership, Process Improvement, Quality System, Fda, Design Control, and Capa.
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