Peter J. Niziolek Email and Phone Number
Peter J. Niziolek work email
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Peter J. Niziolek personal email
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!
Sheffield Pharmaceuticals, Llc
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Quality Assurance ManagerSheffield Pharmaceuticals, Llc Jun 2021 - PresentNew London, Ct, Us
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Post Market Surveillance ManagerCoopersurgical May 2018 - Jun 2021 -
Qms ConsultantValidant Sep 2017 - Dec 2017San Francisco, Ca, UsSupport 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. -
Patina Consulting ProfessionalPatina Solutions May 2017 - Jul 2017Brookfield, Wi, UsPatina 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. -
Senior Quality Systems ManagerMedtronic 2015 - Apr 2017Minneapolis, Mn, UsDirected 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. -
Post Market Surveillance ManagerCovidien (Medtronic Minimally Invasive Therapies Group) 2013 - 2015Fridley, Minnesota, UsChampioned 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. -
Quality Assurance SupervisorTyco Healthcare 2006 - 2013Cork, IeEnhanced 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. -
Post Market Surveillance/Qa AnalystTyco Healthcare 2004 - 2005Cork, IeRecognized 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.
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Technical Services Sr. Project CoordinatorUnited States Surgical Corporation 2001 - 2003
Peter J. Niziolek Skills
Peter J. Niziolek Education Details
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Boston UniversityGeneral -
Southern Connecticut State UniversityPublic Health
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Hamden Hall Country Day SchoolHigh School Diploma
Frequently Asked Questions about Peter J. Niziolek
What company does Peter J. Niziolek work for?
Peter J. Niziolek works for Sheffield Pharmaceuticals, Llc
What is Peter J. Niziolek's role at the current company?
Peter J. Niziolek's current role is Global Quality Systems Leader | Healthcare Innovation | Change Agent | Impacting Talent, Revenue, & Performance.
What is Peter J. Niziolek's email address?
Peter J. Niziolek's email address is pe****@****cal.com
What schools did Peter J. Niziolek attend?
Peter J. Niziolek attended Boston University, Southern Connecticut State University, Hamden Hall Country Day School.
What skills is Peter J. Niziolek known for?
Peter J. Niziolek has skills like Iso 13485, Fda, Quality System, Capa, Iso 14971, Minitab, Complaint Management, Surgical Instruments, Medical Devices, 21 Cfr, Cqa, Operational Excellence.
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