Matthew Manges

Qualification Profile Motivated, accountable, resourceful, and independent with 27 years Engineering and Product Development experience. Primary expertise is... | Randleman, North Carolina, United States

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Matthew Manges’s Location Randleman, North Carolina, United States

Matthew Manges’s Expertise Qualification Profile Motivated, accountable, resourceful, and independent with 27 years Engineering and Product Development experience. Primary expertise is regulatory compliance, implementation of manufacturing processes for new products and Software Development Life Cycle (SDLC-CSQE). Designed complex assembly production lines in entirety including equipment. Managed complete business and quality plans for such products from supply chain acquisition to equipment procurement. Also have validated and wrote all procedures and quality plans for such product lines/processes. Core Competencies Regulatory and Compliance -Risk Analysis and Process Remediation -21 CFR 820, 21 CFR 211, ISO 13485, ISO 11607, ISO 17025, ISO 14971, ISO 12207, GAMP 4 and ISO 17799 -Document Control/DMR, DHR and QSR Procedures -CAPA Implementation and Resolution -NCMR and IQA Issues Process Validation and Improvement -IQ/OQ/PQ Process Validation -DoE, SPC, Gage R&R, and Statistical Analysis -Software Verification and Validation -Six Sigma Business Performance Indexes (BPin) for key corporate metrics -DMAIC, Kaizen, Lean Manufacturing and 5S Principles -Accelerated Aging and Medical Packaging Validation -Sterility Verification and Validation -Microbial Contamination and Control Design Methodology -FMEA -SWOT Risk Analysis -Design for Robustness MTBF and MTTR -DMADV and Phase Transfer Gate keeping Medical Device Manufacturing -Surface Modification and Plasma Treatment -EMA, RF, Thermal and Ultrasonic Welding -Solvent bonding -Wave soldering -Misc. Secondary Assembly Equipment Specialties: ASQ Certifications-SSBB,CBA,CSQE

Matthew Manges’s Current Industry Abbott

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Work Experience

Abbott

Principle Molding Engineer

Mon Mar 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Excela Mold

Company Owner

Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Present

Stryker Orthopaedics

Quality Systems Project Manager, Mahwah NJ

Sun Nov 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time)

Zimmer

QA/RA Consultant, Dover OH

Fri May 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jul 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)

Boston Scientific

QA/RA Consultant, Spencer IN

Thu Nov 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Mar 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time)

Boston Scientific

QA/RA Consultant, Quincy MA

Sat Jul 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Aug 01 2007 00:00:00 GMT+0000 (Coordinated Universal Time)

Moll Industries Medical Division

Project Manager

Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)

Polyfuel

Manufacturing Engineer

Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2003 00:00:00 GMT+0000 (Coordinated Universal Time)

Arch Chemicals

Engineering/Product Development

Mon Jan 01 1996 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time)

Skills

Languages

Matthew Manges Email Addresses

ma****@st****.com Work Email

ma****@st****.com Personal Email

ma****@ex****.com Personal Email

FAQ About Matthew Manges

Matthew Manges is located at
Randleman, North Carolina, United States

Matthew Manges is a
Qualification Profile Motivated, accountable, resourceful, and independent with 27 years Engineering and Product Development experience. Primary expertise is regulatory compliance, implementation of manufacturing processes for new products and Software Development Life Cycle (SDLC-CSQE). Designed complex assembly production lines in entirety including equipment. Managed complete business and quality plans for such products from supply chain acquisition to equipment procurement. Also have validated and wrote all procedures and quality plans for such product lines/processes. Core Competencies Regulatory and Compliance -Risk Analysis and Process Remediation -21 CFR 820, 21 CFR 211, ISO 13485, ISO 11607, ISO 17025, ISO 14971, ISO 12207, GAMP 4 and ISO 17799 -Document Control/DMR, DHR and QSR Procedures -CAPA Implementation and Resolution -NCMR and IQA Issues Process Validation and Improvement -IQ/OQ/PQ Process Validation -DoE, SPC, Gage R&R, and Statistical Analysis -Software Verification and Validation -Six Sigma Business Performance Indexes (BPin) for key corporate metrics -DMAIC, Kaizen, Lean Manufacturing and 5S Principles -Accelerated Aging and Medical Packaging Validation -Sterility Verification and Validation -Microbial Contamination and Control Design Methodology -FMEA -SWOT Risk Analysis -Design for Robustness MTBF and MTTR -DMADV and Phase Transfer Gate keeping Medical Device Manufacturing -Surface Modification and Plasma Treatment -EMA, RF, Thermal and Ultrasonic Welding -Solvent bonding -Wave soldering -Misc. Secondary Assembly Equipment Specialties: ASQ Certifications-SSBB,CBA,CSQE Abbott

Matthew Manges currently works in the
Abbott

Matthew Manges specializes in
Qualification Profile Motivated, accountable, resourceful, and independent with 27 years Engineering and Product Development experience. Primary expertise is regulatory compliance, implementation of manufacturing processes for new products and Software Development Life Cycle (SDLC-CSQE). Designed complex assembly production lines in entirety including equipment. Managed complete business and quality plans for such products from supply chain acquisition to equipment procurement. Also have validated and wrote all procedures and quality plans for such product lines/processes. Core Competencies Regulatory and Compliance -Risk Analysis and Process Remediation -21 CFR 820, 21 CFR 211, ISO 13485, ISO 11607, ISO 17025, ISO 14971, ISO 12207, GAMP 4 and ISO 17799 -Document Control/DMR, DHR and QSR Procedures -CAPA Implementation and Resolution -NCMR and IQA Issues Process Validation and Improvement -IQ/OQ/PQ Process Validation -DoE, SPC, Gage R&R, and Statistical Analysis -Software Verification and Validation -Six Sigma Business Performance Indexes (BPin) for key corporate metrics -DMAIC, Kaizen, Lean Manufacturing and 5S Principles -Accelerated Aging and Medical Packaging Validation -Sterility Verification and Validation -Microbial Contamination and Control Design Methodology -FMEA -SWOT Risk Analysis -Design for Robustness MTBF and MTTR -DMADV and Phase Transfer Gate keeping Medical Device Manufacturing -Surface Modification and Plasma Treatment -EMA, RF, Thermal and Ultrasonic Welding -Solvent bonding -Wave soldering -Misc. Secondary Assembly Equipment Specialties: ASQ Certifications-SSBB,CBA,CSQE

Matthew Manges speaks the following languages:
No languages available.

Matthew Manges has prior experience in the following industries:
Abbott , Stryker Orthopaedics , Zimmer , Boston Scientific , Boston Scientific , Moll Industries Medical Division , Polyfuel , Arch Chemicals

Matthew Manges has the following professional experience:
Abbott , Excela Mold , Stryker Orthopaedics , Zimmer , Boston Scientific , Boston Scientific , Moll Industries Medical Division , Polyfuel , Arch Chemicals .