Suparna Biswas

About Suparna Biswas

Quality Systems Management, Compliance and audits, Document Management Systems, Quality Metrics – in-depth knowledge of ISO 13485, 21 CFR Part 820, 21 CFR 211; Strategic Planning and problem solvingExcel at analyzing complex information and producing high quality technical documentation to meet the needs of end-usersProven ability in report writing and editing: more than ten years of experience in writing scientific and technical papers and reports, research grant proposals, quality manuals and policies, standard operating procedures (SOPs), health and safety manuals, reports for Illinois Environmental Protection Agency (Illinois EPA), and the Illinois Department of Environment (Illinois DOE)Strong knowledge of ISO and FDA regulations related to medical devices and pharmaceuticals, Illinois EPA soil, water, and air regulations, and knowledge of OSHA\'s environmental safety regulationsExcellent project management and coordinating abilities with outstanding quantitative and statistical analysis skillsExcellent communication skills (verbal and written): strong at collaboration and interpersonal communicationsSpecialties: Quality Systems, Audits, Nonconformances, CAPAs, Technical writing, microsoft excel, VISIO, SAS, SPSS, AUTOCAD, strong communication skills, excellent presentation skills, independent research abilities

Experience

1. Senior Manager Audit & Compliance

   Medtronic

   Nov 2023 — Present

Education

• Southern Illinois University at

  M.S, Environmental Sciences

  2000 — 2002

• The Ohio State University

  M.S, Ecology

  2002 — 2005

Skills

• Remediation
• Validation
• Environmental Compliance
• Research
• Autocad
• Pharmaceutical Industry
• Sop
• Fda
• Hardwork
• Visio
• Newsletters
• Training
• Quality Management Systems
• Writing
• Sustainability
• Grant Writing
• Quality Auditing
• Environmental Management Systems
• Environmental Awareness
• Trusted Business Partner
• Highly Dedicated
• Spss
• Technical Writing
• Environmental Science
• Environmental Impact Assessment
• Quality System
• Getting the Job Done
• Environmental Services
• Microsoft Office
• Sas
• Analysis
• Highly Reliable
• Enviromental
• Auditing
• Root Cause Analysis and Capa
• Software Documentation
• Analytical Chemistry
• Trackwise
• Review and Release of Product
• Gmp