Matthew Burger work email
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Matthew Burger personal email
Mission: To utilize my accumulated technical experiences in the medical device field to connect medical device manufacturers with QA/RA subject matter experts in order to provide expert guidance that expedites product releases, ensures compliance or aids organizations with remediation activities, all of which impact patient care.Technical Experience:Supplier Quality Management / RemediationHuman Factors EngineeringManufacturing Processes ValidationQuality Control (Manufacturing)Quality (Design V&V, pre-product release)Risk Management (ISO 14971)FDA 21 CFR Part 820, Part 11, Part 803, Part 807, Part 812Supplier Quality Engineering (including audits)Internal Audits (21 CFR Part 820, ISO 13485, MDD 93/42/EEC, EU MDD, EU MDR, MDSAP)Technical Files / Design Dossier Management510(k) Submissions, CE Certifications, Health Canada LicensingWorldwide Regulatory Strategy Development
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Vice President Of Business Development, Team LeaderRqm+ Jan 2021 - PresentMonroeville, Pa, Us -
Account DirectorRqm+ Jan 2018 - Jan 2021Monroeville, Pa, Us
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Director, Philadelphia OperationsRqm+ Dec 2016 - Jan 2018Monroeville, Pa, Us
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Manager Of Pennsylvania OperationsRqm+ Jul 2014 - Dec 2016Monroeville, Pa, Us
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Senior Regulatory And Quality EngineerRqm+ Nov 2012 - Jul 2014Monroeville, Pa, Us
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Senior Design Quality EngineerPhilips Respironics Dec 2011 - Nov 2012Amsterdam, Noord-Holland, NlPatient Interface (Sleep Apnea Masks / Therapy Devices) Design Quality Engineer. Also monitor and manage the quality agreement with our Asia-Pacific suppliers. -
Senior Design V&V EngineerPhilips Respironics Nov 2006 - Nov 2011Amsterdam, Noord-Holland, NlLead Design Verification and Validation Engineer for developing test methods and procedures for medical devices. Lead efforts in ensuring compatibility between devices and accessories which are FDA controlled products. Assist the Risk Management and Reliability Assurance departments.
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Lead Design V&V EngineerNasal Product Lines Nov 2006 - Dec 2010Responsible for writing and documenting testing for NPD and CI projects for Patient Interface.Supported Post-Market Risk Assessments, Investigations, HHE's and CAPA's.Assist in training fellow engineers and technicians in the department.Temporarily supervised the Design V&V department for a period of 3 months.Co-developed and validated an alteration in test strategy that saves 60-70% on test time.Authored and validated 4 new user friendly protocols for performing System Validation protocols.
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Lead Process EngineerCaptive Plastics Nov 2004 - Oct 2006Lead processing efforts for injection stretch blow molding, stretch blow molding and injection molding. Traveled to Italy for 4 weeks to qualify 4 production tools and a new injection stretch blow molding machine.Oversaw the installation of the injection stretch blow molding machine and downstream equipment from Italy.
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Process Engineer/Project ManagerCaptive Plastics Inc Nov 2004 - Oct 2006Responsible for a new Injection Stretch-Blow machine (Sipa)Traveled to Italy for four weeks to qualify the injection stretch blow molding machine and production tools as well as determining the machine process parameters.Developed QC Plan to release new containers to the PET (food grade) bottling market.Authored P.M. guide/schedule for the SIPA I.S.B.M. and downstream equipment.Authored all of the process parameters as well as a troubleshooting guide for processing.Managed, trained, and wrote S.O.P's for Sipa, Sidel, Nissei, Aoki and Husky production lines.Promoted to Production Manager for a period of 4 months due to an acquisition of another manufacturing facility.
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Design V&V EngineerParadigm Packaging May 2004 - Nov 2004Lead Process Engineer for injection blow molding and injection stretch blow molding.
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Process EngineerParadigm Packaging May 2004 - Nov 2004
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Junior ConsultantPenn State, The Behrend College Mar 2004 - Apr 2004Troubleshooting of solenoid valve design via Pro/Engineer Wildfire, MoldFlow and AnsysPresented findings and solutions to current design errors and methods to prevent errors in future tooling
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InternZurn Plumbing Products May 2003 - Sep 2003Worked on extrusion production lines producing Cross-Linked PE (PEX) pipe to optimize the process, designed new head and die tooling, and set-up a preventative maintenance procedureCreated a complex Microsoft Access program to track line efficiency and scrap on a daily, monthly and/or yearly basisResponsible for the training of Microsoft Access program functions
Matthew Burger Skills
Matthew Burger Education Details
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Point Park UniversityEngineering -
Penn State UniversityEngineering
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Pennsylvania State University, The Behrend CollegePlastic Engineering And Technology
Frequently Asked Questions about Matthew Burger
What company does Matthew Burger work for?
Matthew Burger works for Rqm+
What is Matthew Burger's role at the current company?
Matthew Burger's current role is Vice President Of Business Development at RQM+.
What is Matthew Burger's email address?
Matthew Burger's email address is ma****@****ips.com
What schools did Matthew Burger attend?
Matthew Burger attended Point Park University, Penn State University, Pennsylvania State University, The Behrend College.
What are some of Matthew Burger's interests?
Matthew Burger has interest in Quality Control, Risk Management, Mentoring, Management Training, Career Development, Golf, Travel.
What skills is Matthew Burger known for?
Matthew Burger has skills like Manufacturing, Fda, Injection Molding, Capa, Medical Devices, Engineering, Iso 13485, Design Control, Quality System, Training, Moldflow, Ansys.
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