Maciej "Magic" Grygorczuk

Experience

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  Shanahan Engineering

  Apr 2006 - Nov 2007

  Documentation Controller
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  HKR Architects

  Jan 2008 - Apr 2008

  Documentation Controller
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  Dublin Airport Authority

  Apr 2008 - Feb 2009

  Documentation Controller
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  VoiceCo Networks

  Jul 2009 - Oct 2009

  Computer Data Analyst
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  Nypro

  Oct 2009 - Nov 2013

  Technical Documentation Specialist
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  Jabil Healthcare

  Nov 2013 - now

  Lead Quality System processes, internal audits, Customer audits, ISO 13485 registration audits, FDA inspections; prepare submissions and responses to FDA and ISO registrars when required.Champion and Subject Matter Expert for the Quality Systems and compliance programs.Ensures the site's quality system development, effective maintenance and continued compliance with business unit requirements, medical devi e regulations and standards.Leads department activities within the Quality Systems function (i.e., document and data control, retains and records retention, training, corrective and preventive actions, change control, design control, deviation, supplier audits, supplier corrective actions, electronic system development and validation, management review, risk management, auditing, agency inspections and quality improvement initiatives).Establish, maintain and report Quality System metrics to local team, management and global business units.Enforces safety rules and regulations designed to create and maintain a safe working environment. Responsible for the employment cycle, performance and compensation management, and training and development of assigned direct reports.Coordinate, lead and supervise the daily activities of the team.Apply and support Lean and continuous improvement principles across the team. Show less

  • Design Quality Manager

    Sept 2022 - now

  • Design Control Specialist

    Nov 2013 - Aug 2023