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Peter Niziolek Location
New York, NY, US
Peter Niziolek Work
Quality Assurance Manager @ (June 2021 - Present)
Post Market Surveillance Manager @ (May 2018 - June 2021)
QMS Consultant @ (September 2017 - December 2017)
Patina Consulting Professional @ (May 2017 - July 2017)
Senior Quality Systems Manager @ (January 2015 - April 2017)
Post Market Surveillance Manager @ Covidien (Medtronic Minimally Invasive Therapies Group) (January 2013 - December 2015)
Quality Assurance Supervisor @ (January 2006 - December 2013)
Post Market Surveillance and QA Analyst @ (January 2004 - December 2005)
Technical Services Sr. Project Coordinator @ United States Surgical Corporation (January 2001 - December 2003)
Peter Niziolek Education
Boston University
Bachelor of Arts (BA) (Biology, General)
Hamden Hall Country Day School
High School Diploma
Southern Connecticut State University
Master of Public Health - MPH (Public Health)
Peter Niziolek Skills
ISO 13485
FDA
Quality System
CAPA
ISO 14971
Minitab
Complaint Management
Surgical Instruments
Medical Devices
21 CFR
CQA
Operational Excellence
Six Sigma
Root Cause Analysis
Cross-functional Team Leadership
DMAIC
GMP
SPC
ISO
Quality Assurance
U.S. Food and Drug Administration (FDA)
Corrective and Preventive Action (CAPA)
21 CFR Part 11
Biomedical Engineering
Biotechnology
Design of Experiments
Manufacturing
Research and Development (R&D)
Quality Auditing
Regulatory Submissions
Failure Analysis
Continuous Improvement
Quality Management
Microsoft Office
Life Sciences
Validation
Peter Niziolek Summary
Peter Niziolek, based in New York, NY, US, is currently a Quality Assurance Manager at Sheffield Pharmaceuticals, LLC. Peter Niziolek brings experience from previous roles at CooperSurgical, Validant, Patina Solutions and Medtronic. Peter Niziolek holds a Bachelor of Arts (BA) in Biology, General @ Boston University. With a robust skill set that includes ISO 13485, FDA, Quality System, CAPA, ISO 14971 and more. Peter Niziolek has 3 emails and 4 mobile phone numbers on RocketReach.
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