Denis Mathiowetz Email & Phone Number
Software Compliance Advisory Services @ SQA - Software Quality Associates
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Denis Mathiowetz Location
- Boston, MA, US
Denis Mathiowetz Work
- Software Compliance Advisory Services @ (January 2025 - Present)
- Software Quality Assurance Team Lead @ (November 2023 - January 2025)
- Software Quality Assurance Lead @ (June 2021 - November 2023)
- Software Quality Assurance Lead @ (February 2020 - May 2021)
- Senior Software Quality and Validation Lead @ (November 2018 - November 2019)
- Software Quality Assurance Lead @ (April 2017 - November 2018)
- Senior Software Validation Lead @ (February 2017 - April 2017)
- Software Quality Assurance Lead @ (October 2016 - February 2017)
- Software Quality Assurance Lead and Manager @ (October 2014 - September 2016)
- Computer System Validation Lead and Software Quality Assurance Lead-Consent Decree @ (November 2012 - October 2014)
- Senior Software Quality Assurance and Validation Lead @ (March 2010 - November 2012)
- Software Quality Assurance Lead @ Boston Scientific Corporation (November 2006 - February 2010)
- Software Quality Assurance Lead and Validation Lead @ Other Projects - Part I (June 2004 - November 2006)
- Quality Assurance and Computer Validation Lead-Consent Decree @ Other Projects - Part II (March 2001 - December 2003)
- Software Quality Assurance and Validation Lead @ Other Projects - Part III (January 1999 - March 2001)
- Senior Validation Lead @ Other - Projects - Part IV (May 1995 - December 1998)
- Senior Validation Engineer and Senior Process Engineer @ Other Projects - Part V (July 1991 - May 1995)
- Engineer @ Other Projects - Part VI (April 1988 - July 1991)
- Engineer @ Other Projects - Part VII (January 1986 - February 1988)
Denis Mathiowetz Education
- University of Wisconsin-Madison
B.S. ChE (Major: Chemical Engineering Minor: Computer Science)
Denis Mathiowetz Skills
- 21 CFR Part 11
- Biotechnology
- CAPA
- Change Control
- Cleaning Validation
- Computer System Validation
- Cross-functional Team Leadership
- DMAIC
- Design of Experiments
- Document Management
- Documentation
- FDA
- GAMP
- GMP
- GxP
- ISO
- ISO 13485
- Integration
- LIMS
- Leadership
- Life Sciences
- Management
- Manufacturing
- Medical Devices
- Pharmaceutical Industry
- Process Engineering
- Process Improvement
- Process Simulation
- Project Management
- Quality Assurance
- Quality Auditing
- Quality Control
- Quality Management
- Quality System
- R&D
- Regulatory Affairs
- Regulatory Requirements
- Root Cause Analysis
- SDLC
- SOP
- Six Sigma
- Software Documentation
- Software Quality Assurance
- Technical Writing
- Technology Transfer
- Testing
- V&V
- Validation
- Verification and Validation (V&V)
- Cross Functional Team
- Cross Functional Team Leadership
- Software Quality
- Computer System
- Verification And Validation V&V
- Verification and Validation
Denis Mathiowetz Summary
- Denis Mathiowetz, based in Boston, MA, US, is currently a Software Compliance Advisory Services at SQA Group. Denis Mathiowetz brings experience from previous roles at USDM Life Sciences, Vertex Pharmaceuticals, Philips and Insulet Corporation. Denis Mathiowetz holds a B.S. ChE in Major: Chemical Engineering Minor: Computer Science @ University of Wisconsin-Madison. With a robust skill set that includes 21 CFR Part 11, Biotechnology, CAPA, Change Control, Cleaning Validation and more. Denis Mathiowetz has 4 emails and 1 mobile phone numbers on RocketReach.
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