Experience

arcomed ag

• Switzerland
• Hospitals and Health Care
• 1 - 100 Employee

• Head Of Quality Management & Regulatory Affairs

  • Nov 2019 - Present

  Arcomed AG designs, develops and manufactures infusion pumps for intravenous applications and distributes medical class IIa consumables and class IIb Devices. • Expansion of our quality management system according to ISO 13485 • Management and support of QM-relevant projects • Creation of vigilance, CAPA and post market surveillance processes • Conducting internal audits and preparing for re-certification/re-certification and surveillance audits • Supervision of process and document changes within the scope of the quality management system • Holding internal training courses for quality assurance • Planning and execution of audits of all kinds (worldwide) (ISO, FDA, MDSAP) • Maintenance of technical documentation structure for the MDR certificate • Preparation of the entire approval procedure (technical documentation up to apostille maturity) • Support in the selection of suppliers of consumables around the world • Establishment and expansion of a ProAlpha controlled process network including qualification and validation (Software-Validation) • Execution of validations (DQ-IQ-OQ-PQ) and preparation of risk analyses Risk-Management • Usability Engineering-Process & Use Design Risk Assessment etc. • Introduction of FDA-conform review and qualification processes - Certified TQM- of the consumer goods industry - Certified QM specialist for medical technology - Certified auditor for medical technology - Certified QM consultant for medical technology -Certified Regulatory Affairs Manager for medical technology Standards areas: > Food and Drug Administration (FDA) > ISO 13485:2016 (medical device manufacturing) > MDR: Medical Device Regulation > MDSAP (Medical Device Single Audit Program) > Risk management standard ISO 14971 > IFS (International Food Standard) > BRC (British Retail Consortium) > ISO 9001:2015 & ISO DIN EN 15224 > ISO 14001 environmental management > Software validation (GAMP5) Show less



boneArtis AG

• Brunnen

• Plant Production Manager

  • Sep 2017 - Oct 2019

  Boneartis designs, develops and manufactures bone replacement implants and materials for human bone reconstruction. • Production management of the two production sites in Brunnen. • Carrying out internal and external audits • Preparation of all QMS documentation • Documentation and execution of equipment qualification, sterilization, medical devices, CCs • Deviation and CAPA management • Instructions for test methods, material analysis, technical documentation, regulatory Affairs • Process validation plans and reports • Creation of manufacturing specifications, standard instructions. • Strategic business planning • Personnel management • Successful development to ISO13485 certificate Show less



Früh Verpackungstechnik AG

• Switzerland
• Packaging and Containers Manufacturing
• 1 - 100 Employee

• Application Engineer

  • Jan 2010 - Sep 2017

  Früh are a market leading packaging CMO for the Medical device, pharmaceutical device and food packaging industries. • Responsible for process optimization in the field of flexible packaging for medical / pharmaceutical devices and food packaging • Preparation of packaging development and manufacturing technical documentation • Participation in customer and supplier audits • Management of customer complaint investigations • Responsible for equipment and tool qualification • Preparation of work instructions and training documents • Cooperation in test series and developments in the field of stamping and forming technology as well as Peel-Pouch for the pharm- Area • Execution of process and product and software validations • Responsible for the personnel management in the production area • Performing tactile 3D measurements • Evaluation of CPK requirements and Q-STAT analysis • Creation of requirements documentation focusing on pharmaceuticals and medical technology • Responsible for the QA documentation and management of the documents • Editing Change-Control and Deviation Reports (8-D Reports) • Creation of SOPs, specifications and validation plans • Project work in the area of flexible packaging for the companies, Roche, Novartis and Genentech Show less



Swiss Caps AG

• Kirchberg, Sankt Gallen, Schweiz

• Department Manager Soft Capsule Production

  • Dec 2006 - Dec 2009

  Swiss Caps AG in Kirchberg (today a member of the Aenova Group) is a global company in the field of encapsulation and packaging of hard and soft gelatin capsules for the medical, pharmaceutical and food industries. • Responsible for the training and development of employees • Conducting employee and conflict talks • Organization of the shift group • Development and implementation of continuous improvement processes • Ensuring a smooth production process with regard to quality and quantity • Control of production papers and bookings • Correction of postings in SAP and Hydra • Professional and disciplinary leadership of a shift group of 20 employees Show less