Quality Assurance Manager
Current
Jun 2021 - Present
AeroLeads people directory · profile
Peter J. Niziolek Email & Phone Number
Global Quality Systems Leader | Healthcare Innovation | Change Agent | Impacting Talent, Revenue, & Performance
at
Sheffield Pharmaceuticals, LLC
1 work email found
@sheffieldpharma.com
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Global Quality Systems Leader | Healthcare Innovation | Change Agent | Impacting Talent, Revenue, & Performance
Location
New York City Metropolitan Area, United States
Who is Peter J. Niziolek? Overview
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Quick answer
Peter J. Niziolek is listed as Global Quality Systems Leader | Healthcare Innovation | Change Agent | Impacting Talent, Revenue, & Performance at Sheffield Pharmaceuticals, LLC, based in New York City Metropolitan Area, United States. AeroLeads shows a work email signal at sheffieldpharma.com and a matched LinkedIn profile for Peter J. Niziolek.
Peter J. Niziolek previously worked as Quality Assurance Manager at Sheffield Pharmaceuticals, Llc and Post Market Surveillance Manager at Coopersurgical. Peter J. Niziolek holds Bachelor Of Arts (Ba), Biology, General from Boston University.
Company email context
Email format at Sheffield Pharmaceuticals, LLC
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*@sheffieldpharma.com
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Profile bio
About Peter J. Niziolek
Solid background in FDA & ISO regulations, Project/Budget Management, Complaint Handling, CAPA, HHE, Risk Management (FMEA & FTA), Lean & Six Sigma, Product Stability, Audit Readiness, and CDC/OSHA EH&S practices leading teams to execute global strategies and ensure patient safety. Recognized as an effective project leader in Product Lifecycle Management, Strategic/Capacity/Resource Planning, and Continuous Improvement initiatives that leverage efficiencies and reduce costs. Strengths include, a thorough comprehension of client needs to ensure customer satisfaction working in Fortune 500 healthcare organizations. If you are looking for an innovation leader that will allow you to leverage industry best practices by enhancing your current Quality Management System and promote immediate revenue growth. Let's discuss how we can promote Quality and how the Cost of Quality impacts your organization!
Listed skills include Iso 13485, Fda, Quality System, Capa, and 32 others.
Current workplace
Peter J. Niziolek's current company
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9 roles · 26 years
Peter J. Niziolek work experience
A career timeline built from the work history available for this profile.
Post Market Surveillance Manager
May 2018 - Jun 2021
Qms Consultant
Support and deliver multinational medical device organizations with strategic and tactical plans for Acquisition Due Diligence Activities, QMS/PMS improvements, and EU MDR/IVDR Implementation and budget preparation for multiple business units.
Sep 2017 - Dec 2017
Patina Consulting Professional
Patina is a firm that partners with companies to solve problems, realize opportunities, improve results, fill a key expertise or resource gap, develop talent, or assist with other critical initiatives. This is executed through consulting, projects, leadership/board roles and coaching. My specialties include Audit Readiness by coaching and mentoring Engineering teams on Complaint, Corrective and Preventive Action (CAPA), Supplier Corrective Action Requests (SCAR), & Non-conformance Investigations with regard to implementing Quality Tools, Technical Writing from a Compliance, Regulatory, and Legal perspective.
May 2017 - Jul 2017
Senior Quality Systems Manager
Directed Quality teams supporting 4 Global Business Units to harmonize Complaint Investigation and Root Cause Analysis content in accordance with ISO/FDA standards and best practices. In addition to, leading the implementation and training of the SAP ERP system for the Minimally Invasive Therapies Group. While establishing Quality Metric/KPI Dashboards to track Inventory, Aging, and First Pass Yield for enhanced compliance and audit readiness, acting as the audit lead during Notified Body and Corporate Audits.
2015 - Apr 2017
Post Market Surveillance Manager
Championed dual role managing the Analytics and Investigation teams to drive value added input into departmental process enhancements and business decisions. For example, Enterprise Quality Management System and Quality Agreement assessments, implementing virtual investigations with MFG sites, establishing a Patient Safety Event investigation format, laboratory nomination as the Gold Safety Standard for GLPs, and piloted existing Internship program.
2013 - 2015
~2 yrs
Quality Assurance Supervisor
Enhanced the product test regiment by incorporating QC release, product development, packaging, and biological test methods to provide value added customer feedback. In addition to, workflow enhancements by consolidating laboratory space and streamlining the investigation process utilizing Lean Concepts to increase throughput.
2006 - 2013
~7 yrs
Post Market Surveillance/Qa Analyst
Recognized by Leadership for ensuring high quality standards of the laparoscopic stapling product line attributed to sales exceeding $200M. This effort was accomplished by championing a team of senior representatives from Manufacturing, R&D, Engineering, Regulatory, Marketing, and Sales to develop actionable Key Performance Indicators (KPIs) for visibility during Management Review.
2004 - 2005
~1 yr
Technical Services Sr. Project Coordinator
United States Surgical Corporation
2001 - 2003
~2 yrs
3 education records
Peter J. Niziolek education
Bachelor Of Arts (Ba), Biology, General
Boston University
Master Of Public Health - Mph, Public Health
Southern Connecticut State University
High School Diploma
Hamden Hall Country Day School
FAQ
Frequently asked questions about Peter J. Niziolek
Quick answers generated from the profile data available on this page.
What company does Peter J. Niziolek work for?
Peter J. Niziolek works for Sheffield Pharmaceuticals, LLC.
What is Peter J. Niziolek's role at Sheffield Pharmaceuticals, LLC?
Peter J. Niziolek is listed as Global Quality Systems Leader | Healthcare Innovation | Change Agent | Impacting Talent, Revenue, & Performance at Sheffield Pharmaceuticals, LLC.
What is Peter J. Niziolek's email address?
AeroLeads has found 1 work email signal at @sheffieldpharma.com for Peter J. Niziolek at Sheffield Pharmaceuticals, LLC.
Where is Peter J. Niziolek based?
Peter J. Niziolek is based in New York City Metropolitan Area, United States while working with Sheffield Pharmaceuticals, LLC.
What companies has Peter J. Niziolek worked for?
Peter J. Niziolek has worked for Sheffield Pharmaceuticals, Llc, Coopersurgical, Validant, Patina Solutions, and Medtronic.
How can I contact Peter J. Niziolek?
You can use AeroLeads to view verified contact signals for Peter J. Niziolek at Sheffield Pharmaceuticals, LLC, including work email, phone, and LinkedIn data when available.
What schools did Peter J. Niziolek attend?
Peter J. Niziolek holds Bachelor Of Arts (Ba), Biology, General from Boston University.
What skills is Peter J. Niziolek known for?
Peter J. Niziolek is listed with skills including Iso 13485, Fda, Quality System, Capa, Iso 14971, Minitab, Complaint Management, and Surgical Instruments.
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