Senior Quality Management Consultant & Auditor in Medical Devices

2/2019 – 3/2022

• Development and update of Purchasing and SQM processes
• Supplier qualification and supervision
• Management of supplier-related Non-Conformities (NCs) and Corrective and Preventive Actions (CAPAs)
• Supplier NC and CAPA initiation and supervision
• Planning, organisation, preparation and performance of supplier audits incl. follow-up
• Preparation and negotiation of Supplier Quality Agreements
• Supplier classification and development
• Performance of internal audits and staff training in preparation for third party audits

Auditor, Audits, Lieferantenbewertung, Lieferantenentwicklung, Lieferantenmanagement (allg.)

3/2017 – 11/2017

• Support in development and implementation of NC/ CAPA procedures
• CAPA Remediation, Management & Follow-up
• CAPA & GDocP-Training & Consulting
• Performance of Quality System Gap Analyses 21 CFR 820 & Follow-ups

Qualitätsmanager

11/2015 – 12/2022

• Support in development of supplier quality audit process and documentation
• Organisation, preparation and realisation of supplier audits
• Follow-up and documentation on audit findings
• Organisation, preparation and realisation of internal audits
• Training of novice supplier quality auditors and supervision of supplier audits as co-auditor
• Preparation and follow-up of supplier quality agreements

Auditor, Audits, Lieferantenmanagement (allg.)

11/2013 – 9/2015

• Implementation of new processes and standards in Supplier Management
• Management of supplier-related Non-Conformities (NCs) and Corrective and Preventive Actions (CAPAs)
• Implementation, organisation and management of Material Review Boards and Supplier Review Boards
• Preparation and negotiation of Supplier Quality Agreements
• Organisation, preparation and realisation of supplier audits incl. follow-up Support for process validation at supplier and maintenance of a supplier validation master plan
• Support for supplier selection and qualification
• Support for Third-Party audits (ISO 13485 and 21 CFR 820) for suppliers

Auditor, Lieferantenentwicklung, Lieferantenmanagement (allg.)

2/2009 – 11/2013

• Development, implementation and maintenance of a quality management system for the company as well as for two additional companies of the S. group (ISO 13485 & ISO 9001)
• Development, implementation and enhancement of quality relevant processes
• Development and maintenance of technical documentation for medical software products in cooperation with software development (ISO 62304 & ISO 62366)
• Development and maintenance of risk management for medical products (ISO 14971)
• Organisation and realisation of internal audits
• Coordination, preparation and follow-up on Third-Party audits
• Planning and realisation of regular staff trainings on quality relevant topics

Auditor, Qualitätsmanagement / QS / QA (IT), Qualitätsmanager, Regulatory Affairs Manager

3/2005 – 3/2009

• Development of global product marketing
• Implementation of a Corporate Identity strategy
• Design and implementation of marketing concepts and communication strategies
• Support of business partners and dealers worldwide

Marketing Manager