Joachim Paap

Medical Device Q&R Compliance, Chemgineering Business Design GmbH

Joachim Paap has more than 18 years of experience in the medical device industry in Quality, Regulatory & Compliance (product classes I to III). For many years he worked for internationally operating and leading medical device manufacturers as Q&R Manager (Quality Management Representative), Director Q&R Compliance, Q&R Trainer and Senior Auditor.

During his career Joachim Paap has been active throughout Europe, North, Central and South America, Africa, Middle East, India, Asia and Australia.

Competences

• Global QMS Compliance for Medical Device Companies (e.g., ISO 13485: 2016, ISO 9001: 2015, US FDA QS Reg, EU MDR, Canadian CMDR, Anvisa RDC 16, jPMD, MDSAP, ISO 62304)
• QMS design and implementation
• Internal Quality Assurance Agreements
• Certification Landscape
• Audit – Program Management
• Internal audits
• QMS – gap analysis
• QMS remediation, including process and SOP re-design
• Inspection / NB audit preparation
• front office / back office management for inspections (e.g., US FDA) and audits (NBs)
• Q & R Education programs
• Q & R Training Design & Delivery (Classrooms & Webinars / E-Learning)
• Auditor Training and Qualification
• GDP – Good Documentation Practices
• Q & R Supplier Management, including Quality Assurance Agreements
• Global Supplier Qualification & Audits, incl. Distributors
• Six Sigma Management