Dan Mazur

Dan Mazur Email and Phone Number

Independent Consultant @ Quality Assurance & Compliance
Marquette, MI, US
Dan Mazur's Location
Marquette, Michigan, United States, United States
Dan Mazur's Contact Details

Dan Mazur personal email

n/a
About Dan Mazur

QUALITY MANAGEMENT PROFESSIONALQMS Compliance and Management | P&PC | Auditing | CAPA | TrainingComprehensive experience in establishing compliance with current regulations and standards including, CFR 820, 211, CMDR, MHLW Ord. 169, ISO-13485, ISO-9000. Demonstrated success in collaborating and effectively managing cross-functional teams to assess, develop and implement quality management systems. Authored QMS documentation, presented and articulated complex regulation and standards information to all levels of management and staff. Expertise includes, but is not limited to:• Management of Quality Assurance• Manufacturing, Design, Supplier and Controls• QMS and Audit Processes• Process, Metrics/Data Analysis• QMS Requirements and Quality Auditing Instructor• Project Management

Dan Mazur's Current Company Details
Quality Assurance & Compliance

Quality Assurance & Compliance

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Independent Consultant
Marquette, MI, US
Dan Mazur Work Experience Details
  • Quality Assurance & Compliance
    Independent Consultant
    Quality Assurance & Compliance
    Marquette, Mi, Us
  • Philips
    Senior Manager Quality Compliance
    Philips Aug 2018 - Present
    Marquette, Michigan, United States
  • Rti Surgical®
    Director Of Quality Assurance
    Rti Surgical® Aug 2016 - Apr 2018
    Marquette, Mi
    Directed and championed all activities related to the quality management system and leads a team of quality professionals engaged in implementation policy and procedures for operational quality assurance and quality systems compliance. Responsible for leadership and management of the QA department (25 people) including the overall Quality Management Systems, Complaint Handling, Medical Device Reporting, Field Actions, CAPA, Auditing, Quality Engineering, Acceptance Activities, Metrology, Supplier Quality, Documentation Management, Labeling.
  • Ge Healthcare
    Senior Global Compliance Auditor
    Ge Healthcare Jun 2007 - Dec 2015
    Northeast Illinois / Southeast Wisconsin
    MBA, CQM/OE, CQE, CBA, CQA, CLA.Managed, led and conducted Quality Management System audits for the Global Quality Compliance group to evaluate global compliance with CFR Title 21, ISO 13485 and other related standards and regulations. Involved with all aspects of the quality management system (QMS). Led and participated in multiple projects designed to evaluate compliance with regulatory requirements and determine key metrics for audit results.
  • Baxter Healthcare
    Senior Quality Manager
    Baxter Healthcare Aug 2004 - Jun 2007
    Northeast Ilinois
    Directed activities related to the quality system compliance and registration. Involved with all aspects of the quality management system (QMS) development and compliance to the CFR Title 21 Parts 211 & 820, ISO13485 and other related standards/regulations. Member of the Corporate Auditing Council/Staff and led/conducted site and supplier audits. Served as program manager for the Corporate Quality System Improvement Program.
  • Medtronic
    Senior Manager Of Quality Systems
    Medtronic Nov 1999 - Aug 2004
    Warsaw, Indiana
    Directed activities related to the quality management system and regulatory compliance. Involved with all aspects of quality system development and compliance to the CFR Title 21 Section 820, ISO13485, ISO46000 and other related standards. Supervision and direction of activities of Internal Auditors, Supplier Auditors, Corrective Action system and Document Control systems. Accountable for development and execution of departmental budgets.
  • Pleiades International, Inc.
    Senior Consultant / Account Manager
    Pleiades International, Inc. 1995 - 1999
    Westfield, Indiana
    Provided consulting and training to clients in QMS implementation for CFR 820, ISO-13485, ISO-9000, QS-9000, AS-9000, AQS D1-9000 and ISO-14000 and handled all aspects of contract management. Directed activities of field consultants.
  • Eaton
    Plant Quality Manager
    Eaton 1986 - 1995
    North Manchester, Indiana
    Managed the Quality Department and directed quality programs and the activities of the Quality Engineering and Inspection staff. Responsible for all aspects of the quality management system and quality programs. Development and execution of departmental budgets.

Dan Mazur Skills

Fda Design Control Iso 13485 Quality System Capa Quality Auditing Cqa 21 Cfr Part 11 V&v Gmp Medical Devices Auditing Six Sigma Dmaic Validation Manufacturing Regulatory Requirements Sop Change Control Iso 14971 Computer System Validation Regulatory Affairs Gxp Quality Management Regulatory Submissions Fda Gmp Certified Quality Auditor U.s. Food And Drug Administration Corrective And Preventive Action 21 Cfr

Dan Mazur Education Details

Frequently Asked Questions about Dan Mazur

What company does Dan Mazur work for?

Dan Mazur works for Quality Assurance & Compliance

What is Dan Mazur's role at the current company?

Dan Mazur's current role is Independent Consultant.

What is Dan Mazur's email address?

Dan Mazur's email address is daniel.r.mazur@ge.com

What schools did Dan Mazur attend?

Dan Mazur attended Elmhurst College, University Of Saint Francis.

What skills is Dan Mazur known for?

Dan Mazur has skills like Fda, Design Control, Iso 13485, Quality System, Capa, Quality Auditing, Cqa, 21 Cfr Part 11, V&v, Gmp, Medical Devices, Auditing.

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