Carl Shubitowski

Carl Shubitowski Email and Phone Number

Director of Quality & Regulatory, AION Biosystems @ Cube Recovery
Somerville, MA, US
Carl Shubitowski's Location
Somerville, Massachusetts, United States, United States
Carl Shubitowski's Contact Details
About Carl Shubitowski

Experienced as a Quality Assurance Manager with FDA Regulatory and QMS experience. ISO13485 certified auditor, with working knowledge of FDA 21 CFR 820, Health Canada MMD, and European MDR.

Carl Shubitowski's Current Company Details
Cube Recovery

Cube Recovery

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Director of Quality & Regulatory, AION Biosystems
Somerville, MA, US
Carl Shubitowski Work Experience Details
  • Cube Recovery
    Cube Recovery
    Somerville, Ma, Us
    View
  • Aion Biosystems
    Director Of Quality And Regulatory
    Aion Biosystems Jan 2022 - Present
    Darien, Ct , Us
    View
  • Becton Dickinson Company (Safety Syringes, Inc. )
    Quality Engineer
    Becton Dickinson Company (Safety Syringes, Inc. ) May 2021 - May 2022
    San Diego, Ca, Us
    View
  • Omniguide
    Senior Quality Engineer
    Omniguide Apr 2021 - May 2021
    Billerica, Ma, Us
    View
  • Third Pole Therapeutics
    Principal Quality Engineer
    Third Pole Therapeutics Feb 2018 - Jan 2021
    Waltham, Ma, Us
    View
  • Microline Surgical
    Qe Manager
    Microline Surgical Dec 2015 - Nov 2017
    Beverly, Ma, Us
    Managed CAPA, Non-Compliances, Complaints, Doc Control and Incoming Inspection. Improved supplier quality to reduce incoming defects by 50%. Reduced backlog in complaints and improved the trending reporting after the company struggled with a new complaint software system. Conducted 2 product recalls including authoring Health Risk Assessments.
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  • Precision Engineered Products Llc (Pep)
    Quality Assurance Manager
    Precision Engineered Products Llc (Pep) Mar 2015 - Nov 2015
    Attleboro, Ma, Us
    Managed a team of incoming inspectors and a QE. Hosted notified body and supplier audits. Communicated with suppliers to understand what they wanted and improve our quality. Authored 4 validation IQ, OQ, and PQs and ran the validations reporting test results.
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  • Boston Scientific
    Sr. Quality Systems Engineer
    Boston Scientific Jul 2014 - Mar 2015
    Marlborough, Ma, Us
    Worked with start-up company bought by Boston Scientific to merge there Quality System and CAPA program into Boston Scientific's. Ran the CAPA program and migrated the paper system to an electronic system.
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  • Siemens Healthcare
    Advanced Development Engineer
    Siemens Healthcare Nov 2013 - Feb 2014
    Forchheim, De
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  • Stryker Medical
    Principal Advanced Manufacturing Engineer
    Stryker Medical Feb 2011 - Oct 2013
    Worked with out state plant to bring a manufacturing process and product back to Michigan.Worked with the product team to lead the advanced manufacturing portion of a new hospital mattress with a flawless launch.Designed and installed a new hospital bed assembly line, required because of a product change.Completed GD&T Intermediate training.Studied and reviewed IEC 60601-1 new standard for medical devices to make sure we implemented the correct testing protocol.

Carl Shubitowski Skills

Fmea Design Of Experiments Ppap Root Cause Analysis Lean Manufacturing Manufacturing Manufacturing Engineering Six Sigma Spc Automotive Dmaic Continuous Improvement Pfmea Supplier Quality Engineering Cross Functional Team Leadership Apqp Gd&t Testing Manufacturing Operations Management Dfmea Design For Manufacturing Kaizen Quality System 5s Value Stream Mapping Engineering Management Iso Process Improvement Product Development Process Engineering Capa Problem Solving Medical Devices Failure Mode And Effects Analysis Geometric Dimensioning And Tolerancing Business Process Improvement Statistical Process Control Geometric Dimensioning

Carl Shubitowski Education Details

  • University Of Michigan
    University Of Michigan
    Chemical Engineering
  • Kettering University
    Kettering University
    Engineering; Sustainable Energy & Hybrid Technology

Frequently Asked Questions about Carl Shubitowski

What company does Carl Shubitowski work for?

Carl Shubitowski works for Cube Recovery

What is Carl Shubitowski's role at the current company?

Carl Shubitowski's current role is Director of Quality & Regulatory, AION Biosystems.

What is Carl Shubitowski's email address?

Carl Shubitowski's email address is cr****@****ail.com

What schools did Carl Shubitowski attend?

Carl Shubitowski attended University Of Michigan, Kettering University.

What skills is Carl Shubitowski known for?

Carl Shubitowski has skills like Fmea, Design Of Experiments, Ppap, Root Cause Analysis, Lean Manufacturing, Manufacturing, Manufacturing Engineering, Six Sigma, Spc, Automotive, Dmaic, Continuous Improvement.

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