With over 25 years of experience, Jan has a comprehensive background in Quality, Regulatory Compliance, Design, Operations, and Project Management in Medical Devices, Invitro-Diagnostics and Combination Products with some of the largest and most respected companies, as well as small/mid-sized start-ups.
Most recently, Jan served as the project team lead for multiple clients at Validant. While consulting, Jan’s responsibilities included leading Quality Management System integrations for multiple product/company acquisitions and divestitures, tech transfers and plant closures, preparation for Notified Body audits and agency inspections and leading backroom activities during audits/inspections, quality system harmonization and remediation, Risk Management remediation, project management for New Product Introductions, rebranding & labeling associated with changes in the EU Authorized Rep and Notified Bodies, implementation of ISO 14971:2012, ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP), as well as planning for the European Union Medical Device Regulation (EU MDR). Jan has led multiple Quality System area improvements including CAPA, Design Control, Risk Management, Supplier Management, Documentation Control and Post-Market Surveillance.
Previously, Jan held various roles within Beckman Coulter including Q.A., Q.C., Quality Systems and Compliance, Manufacturing Engineering, Corporate Auditing, Packaging & Cold Chain Process Development, Supplier Management, OEM/CMO Process Development, Logistics (Warehousing & Transportation) Quality Systems and Validation Process Development, Due Diligence Team, Process Integration Team Lead, Compliance Remediation Team, Value Engineering, and Management Representative. Jan received her Bachelor of Science degree in Mechanical Engineering from California State Polytechnic University, Pomona and her Masters of Business Administration from the California State University, Fullerton. She is a Licensed Mechanical Engineer in the state of California, a Six Sigma Black Belt, an RABSQA Lead Auditor, has an ASQ Certification in Quality Engineering, and a Kempner-Trego certificate in Project Management.