Project leader and compliance specialist in developing IVDR and ISO 13485/CFR 820 processes within the Quality and Regulatory Department.

Siemens Healthcare Molecular Diagnostics – Molecular, Berkeley, CA May 2012 – Sept 2020Sr. Manager of Quality Systems, May 2012 – Sept 2020Oversaw the management of the internal & external audits, document control, training, corrective and preventive action program, quality assurance, engineering change orders, complaint, FCA, safety reporting, quality improvements, and EQMS development projects; Lead trainer for CAPA and QMS.• Managed the audit readiness program resulting in >3 years with no findings for the site and no external audit findings in area of responsibility for > 5 years; eliminated CAPA findings from audit.• Optimized and drove QMS improvements for training, internal audit, CAPA, and audit readiness; lean processes while ensuring alignment with corporate improvement initiates.• Lead and Supported multiple divisional and global QMS integration projects.• Berkeley site super admin for CAPA-CATSWEB, Lotus Notes training and document control.• CAPA Train the Trainer & QMS Trainer.• Sourced EQMS pilot for document control, training, change control, CAPA and audit program.

Internal Audit and Training Manager/QS Compliance Engineer, May 2009 – May 2012Headed all internal audits and trainings. Supported document control management. Participated in global quality audit and global process optimization, CAPA review, product health, and site safety teams.• Facilitated employee training and development of auditors through the internal audit program in areas of: Lead auditor training, GMP, FDA 21 CFR, QSIT, ISO 13485, root cause analysis, and CAPA.• Performed live training on the Division-wide QMS, new hire orientation.• Participated in multiple audits with no major findings related to training or the. internal audit program.• Authored and implemented improvements through local & global SOP’s and training presentations.

Engineering ServicesDesignated Complaint UnitCAPA and Training DB ManagementSupply Chain Project Management

Opened and managed the Northern California regional office to provide Global technical and design change support.