Drsc John Hartigan is a highly qualified professional, that works in Resoundant main office of which is in 521. on the position of Vice President, Qa and Ra from 2019. This expert gained professional experience in more than 11 positions at different companies. Drsc John Hartigan went to the University of Southern California and got education from 2014 to 2018. This professional has these qualifications: Cqe, Csqe, and Iso 13485 Lead Auditor. Minneapolis, Minnesota is the city, where the professional was lastly known to be situated. This expert's email address and phone number are accessed through this website on demand.
Name variants:
Drsc Hartigan
Last updated Sep 21, 2024
Contact Information
Last Update
Jul 6, 2022
Location
Minneapolis, MN
Company
Resoundant
Workplace
Vice President, Qa and Ra
Work History
Vice President, Qa and Ra
421 1St Ave southwest SUITE 204W, Rochester, MN 55902
from Oct 2019
Consulting and Contractor
Medical Products Consulting, LLC. (Sept/2018 - present) St Paul, Minnesota Regulatory Consultant: Standards and requirements analysis for early AIMD development. Rochester, Minnesota QA/RA C...
from Sep 2018
Director, Quality Assurance and Regulatory Affairs
1775 Corporate Dr SUITE 150, Norcross, GA 30093
Class II
Implantables/Resorbables/Animal-origin
Site Quality & Regulatory leader
MDSAP / 13485:2016 QMS conversion
Technical File Remediation MDR (2017/745), and MEDDEV 2.7/1 rev. 4
US...
Jun 2017 — Jun 2018
Global Quality Systems Manager
5200 Illumina Way, San Diego, CA 92122
ILLUMINA, Inc. Biomedical Industry (IVD) for Molecular Diagnostics and Genomic Testing
Global Quality Systems Manager:
Quality System harmonization / management across 10 different sites ...
Apr 2016 — Aug 2016
Global Compliance Manager
Class II
Complex/Configurable Systems, Imaging/Diagnostic
Strategic / Tactical / Operational planning and roll-out of corporate initiatives, regulatory authority preparation & response, d...
Jun 2009 — Oct 2015
Senior Quality Systems Manager
710 Medtronic Pkwy, Minneapolis, MN 55432
Class III
AEDs
Served as Deputy Management Representative for the QMS and company interface with regulatory agencies, managed FDA establishment inspections and TUV QS surveillance audits
...
Sep 2006 — Sep 2008
Quality Assurance Manager
34931 southeast Douglas St #200, Snoqualmie, WA 98065
Combination Medical Device: Class II Device with Injectable Drug (PMOA
Drug)
Set Quality Policy, wrote and maintained Quality Manual, established and managed budgets and staff, trained ot...
2005 — 2006
Senior Software Quality Engineer and Project Manager
Neenah, WI
Contract Manufacturer
Class II / III development
Internal auditor, verified and validated medical device software to include risk management and software development life cycle activities...
2000 — 2005
Quality Engineer
Class III Implantable
High volume/Low mix:
First Article, Receiving/In-process inspection plans, statistical rationale
Validated processes to include tests for residual solvents, purity,...
1997 — 2000
Analytical Chemist
Semi-Conductor Industry:
Research and Development of polymeric materials, processes, and new product lines used in semi-conductor wafer fabrication, surface bonding and adhesion performanc...
1996 — 1997
Quality Assurance Manager
Assured compliance with GLP, EPA, and in-house protocol, calibration, reports, data review,
QAU for incoming sample custody and identification to assure sample stability, data entry, LIMS
...
1994 — 1995
Education
2014 — 2018
2010 — 2014
2006 — 2009
1990 — 1993
Occupations
Executive
Vice President
Contractor
Counselor
Doctor
Neuropsychiatrist
Cardiologist
Chief Executive
Independent Business Owners
Advisor
Neurological Specialist
Neurologist
Surgical Specialist
Skills
Quality System
Fda
Regulatory Affairs
Iso 13485
Capa
Medical Devices
Quality Assurance
Quality Management
Quality Auditing
Validation
U.s. Food and Drug Administration
Software Quality Assurance
Management
Gmp
Design Control
Iso
V&V
21 Cfr Part 11
Iso 14971
Corrective and Preventive Action
Testing
Clinical Development
Change Control
Medical Device Directive
Cross Functional Team Leadership
Iso Standards
Combination Products
Financial Analysis
Ce Marking
Six Sigma
Research and Development
Project Management
Verification and Validation
Business Management
International Regulatory Affairs
Udi
Complaints/Surveillance
Mdr's
Good Laboratory Practice
Design of Experiments
Computer System Validation
Biotechnology
Statistical Process Control
Product Development
Manufacturing
Standard Operating Procedure
Quality Control
Ddt/Mddt
Cdisc Standards
FAQs about Drsc John Hartigan
What's the main profession of Drsc John Hartigan?
Drsc John Hartigan is a Vice President, Qa and Ra.
What jobs is Drsc John Hartigan proficient at at?
Drsc John Hartigan is a professional such jobs as Executive and Vice President.
Where is Drsc John Hartigan currently located?
Drsc is located in Minneapolis, Minnesota.
Where did Drsc John Hartigan work?
The professional worked at Resoundant, Medical Products Consulting.
What education does Drsc John Hartigan have?
Drsc studied at the University of Southern California from 2014 to 2018.
Are there any professional certifications, that Drsc John Hartigan has?
Drsc John Hartigan received the following certifications: Cqe, Csqe, Iso 13485 Lead Auditor, Biomedical Regulatory Affairs, and Clinical Auditing.
What is the industry that Drsc John Hartigan is connected to?
This professional works in Medical Devices industry.
Are there any special skills, that Drsc John Hartigan has?
Drsc has the following skills: Quality System, Fda, Regulatory Affairs, Iso 13485, Capa, Medical Devices, Quality Assurance, Quality Management, Quality Auditing, and Validation.