Freelancer / QM Consultant in the field of medical technology and pharmacy

For example:

• Stryker Trauma GmbH**

• Qualification of production facilities and process validations of a new production line for the manufacture of implants incl. URS, IQ, OQ and PQ.

• Abiomed Europe GmbH**

• Quality remediation project (optimization of procedures, SOP and test methods and work instructions incl. change management)

• Project Lead for a test method validation

• CAPA Management

• Non-Conformance management

• Gap analysis

• Project Lead: Outsourcing of an internal production process and design change
• Core team member of Quality for int. strategic projects
• Responsible for all quality concerns of needle manufacturing and finished good production
• Qualification, process and test method validation
• Sampling incl. sample sizes for validation and production
• Monitoring
• Data integrity and FDA 21 CFR Part 11 compliance
• Non-Conformance (especially risk assessment, bounding and product disposition)
• Risk management (especially pFMEA) production processes
• CAPA and internal audit
• Audit readiness
• EHS&S responsible for Quality

• Process engineering; Desulfurization of biogas
• Sale of desulfurization substances