Key Areas of Expertise
- Quality Management Systems (QMS) and FDA Compliance (21 CFR 820, 21 CFR 11)
- Manufacturing Process Improvement and Lean Engineering
- Supplier Quality Audits and Remediation Projects
- Risk Management and Hazard Analysis (FMEA, HACCP)
- UDI Implementation and Product Lifecycle Management
- Process Qualification and Validation (IQ, OQ, PQ)
Professional Experience
Medical Devices and Pharma Consultant – Gupta Consultants
Austin, TX | Feb 2014-Present
- Performs quality system, supply chain, and supplier audits, identifying compliance gaps and implementing remediation plans.
- Conducts risk analysis, nonconformance investigations, and root cause analyses for corrective actions (CAPA) with cross-functional teams.
- Leads UDI compliance projects, coordinating with quality engineering and product teams to establish unique device markings and validate processes according to FDA and ISO guidelines.
Quality Management Systems Consultant – Sanofi Biologics
Framingham, MA | March 2022-Aug 2022, Oct 2020-Dec 2020
- Reviewed nonconforming deviations, performed RCA, developed CAPA actions, and documented corrective action plans in Phenix system for quality engineering.
Quality Management and Risk Consultant – Sanofi Genzyme Biosurgery
Framingham, MA | July 2019-Feb 2020
- Conducted operational risk management assessments, including FMEA and HACCP, for aseptic environments. Reviewed batch records, procedures, and environmental qualifications to meet ISO and EU-MDR standards.
Operational and Risk Management Consultant – Ventana Medical Systems (Roche Diagnostics)
Tucson, AZ | May 2019
- Conducted Gemba walks, operational gap assessments, and process flow mapping for semi-auto fill equipment in aseptic manufacturing, resulting in improved operational efficiency and compliance.
Quality Systems and Process Management Consultant – Philips Healthcare
Bothell, WA | Feb 2017-Dec 2018
- Identified over 300 compliance gaps in quality management and supply chain processes, leading remediation efforts and assisting in response to FDA audits and consent decrees.
- Validated facility systems and created a business continuity plan, optimizing resource and facility management.
Manufacturing and Project Engineering Consultant – INTEGRA Life Sciences
Austin, TX | May 2016-Jan 2017
- Led UDI implementation project, including validation plans, process mapping, and supplier qualification. Designed experiments to assess impact of cleaning and sterilization on UDI markings.
Manufacturing and Project Engineering Consultant – Medtronic MiniMed
Northridge, CA | Feb 2016-Apr 2016
- Supported new product integration, conducted time studies, developed decontamination and cleaning plans, and collaborated on CAPA initiatives for implantable devices.
Manufacturing and Project Engineering Consultant – Edwards Lifesciences
Irvine, CA | Oct 2015-Nov 2015 and Draper, UT | Feb 2015-Jul 2015
- Designed packaging solutions and led cleanroom compliance projects for UDI labeling. Coordinated equipment procurement and managed process validation (IQ, OQ, PQ) for new equipment in sterile environments.
Industrial and Project Engineering Consultant – Various Companies
Locations include Greatbatch, Fort Wayne, IN; Fujifilm Dimatix, Lebanon, NH; Mentor Texas (Johnson & Johnson), Irving, TX; Bell Helicopter, Amarillo, TX | 2010-2012
- Conducted value stream mapping, operational studies, and lean transformation projects across multiple sites. Provided layout optimization, bottleneck resolution, and process flow improvements.
Senior Manufacturing Engineer – Adams Thermal System
Canton, SD | 2012-2013
- Led lean manufacturing initiatives, achieving a 40% reduction in non-value-added tasks and improving product quality by 60%.
Principal Industrial and Manufacturing Engineer – Applied Materials
Austin, TX | 2000-2002
- Spearheaded cleanroom packaging and ergonomic studies, enabling smooth transition to high-volume production and reducing packaging material waste.
Education
Master of Manufacturing Systems Engineering (Extension Program)
University of St. Thomas, St. Paul, MN
Senior Certificate in Business Administration
University of Minnesota, Minneapolis, MN
Bachelor of Mechanical Engineering (Industrial and Systems Engineering emphasis)
University of Minnesota, Minneapolis, MN
Certifications and Training
- APICS Certified in Supply Chain Management, Planning and Scheduling, and Project Management
- Kepner-Tregoe Certification in Business Process Improvement (BPI)
- Lean Manufacturing, Quality Management (Juran), Six Sigma, Toyota Production Systems
Achievements
- Implemented UDI compliance program for medical device clients, improving traceability and regulatory adherence.
- Streamlined supply chain processes, increasing productivity by 60% for leading global clients.
- Reduced nonconformance rates by 40% through risk management and CAPA initiatives.
Skills
- Proficient in MS Office, AutoCAD, SolidWorks, ERP systems (Agile, SAP, Oracle).
- Extensive experience in FDA regulations (21 CFR 820), ISO 13485, EU-MDR, MDSAP compliance.