MICHAEL SCHAEFER

My skill set

My skill set
A quality system on its own will not improve product or process quality. Applying suitable tools and methods are crucial to ensuring long-term success and customer satisfaction.  Over the past years I was privileged to develop further my own skillset to implement both compliant and cost-efficient quality systems by focusing on patient safety and error prevention. Take a look into my skill set!

Freelancing and technical (ghost)writing

Freelancing & technical (ghost)writing

 quality engineering statistics and other quality tools

Quality Engineering

ISO 13485 MDR 2017/745 21CFR820

Regulatory Affairs and Quality Management

Risk Management ISO 14971 Harms Severity

Safety Risk Management

Process Validation IQ OQ PQ

Process Validation

Design Control ISO 13485 21CFR820

Design Control

CAPA Corrective and preventive actions

CAPA

Third party auditing internal audit mock inspections

Auditing

Address

Heiligkreuzstrasse 59,
72379 Hechingen Germany

Phone

+49(0)74719301237

Email