Experience

HOYA Surgical Optics

• Singapore
• Medical Equipment Manufacturing
• 200 - 300 Employee

• Senior QA Manager EMEA/Quality Management Representative/PRRC Authorized Representative

  • Sep 2021 - Present

  Distribution Quality, Supplier Quality Management, Person Responsible for Regulatory Compliance for EU-Authorized Representative, Quality Management Systems, Lead Auditor, Project management, Line management, MDR, ISO 13485, ISO 14155, ISO 14971, CAPA, Management Review, KPI, Complaint Management, Vigilance Distribution Quality, Supplier Quality Management, Person Responsible for Regulatory Compliance for EU-Authorized Representative, Quality Management Systems, Lead Auditor, Project management, Line management, MDR, ISO 13485, ISO 14155, ISO 14971, CAPA, Management Review, KPI, Complaint Management, Vigilance



Fresenius Medical Care

• Germany
• Hospitals and Health Care
• 700 & Above Employee

• Head of Quality Systems

  • Oct 2014 - Aug 2021

  Deputy of Director Quality Operations, Quality Management Systems, Corporate Lead Auditor, Project management, Line management, ISO 13485, 21 CFR 820, ISO 14971, GMP, cGMP, CAPA, Management Review, KPI, Change Control, Risk management, FMEA, Validation, Qualification, ISO 15378, GMP Packaging

• Project Coordinator Microbiology

  • Nov 2013 - Sep 2014

  Projectmanagement, LIMS, assay automation, processanalysis and -optimization, Biostoffverordnung



ZMBH, University of Heidelberg

• Research scientist (Postdoc)

  • Feb 2012 - Jun 2013

  Research on microbial protein networks and development and optimiza- tion of new fluorescence microscopy techniques for protein-protein interaction screenings

• PhD student

  • Dec 2007 - Feb 2012

  Research on microbial protein networks using molecular genetics and fluorescence microscopy