MICHAEL SCHAEFER
Freelancing and technical (ghost)writing
Freelancer and Technical (Ghost)Writer
As a freelancer I support your business in short-term firefighting activities (like inspection readiness, audit support or vigilance activities) as well as long-term partnership (like product development, QMS certification or staff coaching). You may qualify me as your service provider and/or I just act as your technical (ghost)writer in the background. You are choosing the model tailored to your needs.
Download: Consultant Profile
Current and past projects
Since January 2014, I am freelancing and consulting as expert for Quality Management Systems and Regulatory Affairs for Medical Devices. Current and past projects in different international companies include
- PRRC as per article 15 EU 2017/745 (MDR),
- MDR preparation Stage 1 and stage 2, including mock audits,
- TD assessment,
- Computersystemvalidation,
- IQ, OQ, PQ,
- Test method validation,
- Statistical sampling plans,
- FDA readiness and mock inspections
- Interim Quality Management Representative (Class I-III),
- Design & development, including drug device combination products (MDR article 117) and medical face masks as per EN 14683,
- Production transfer including Clean Room Validation,
- Auditing (internal, external, supplier, mock inspections),
- Laboratory Management ISO 17025.
Expert for Quality Management Systems and Regulatory Affairs
As mechanical engineer by training I am working in medical devices since 2001. After starting-up with the basics in manufacturing for balloon catheters and cardiac stents, I got responsible for quality engineering, process validation and deployment of six-sigma tools within development and manufacturing of drug eluting stents both in Germany and Ireland. Global Management of Pre-Production Quality and Regulatory Affairs for dialysis disposables added extensive knowledge about communication and interaction with authorities and notified bodies to my portfolio. By combining the requirements for worldwide submissions with the toolbox of Quality Management systems, I was able to shorten timelines for registration significantly and increase compliance to international standards and regulations. Having been a Quality Director in a high volume manufacturing environment for urology catheters and airway management products, I enjoyed finally three years of decision making, problem solving and simplifying quality work flows. Making quality operations management both a compliant and value adding activity was probably one of the things I am most proud of having accomplished. As a freelancer I gained huge experience by both consulting industry and auditing for notified bodies.
Address
Heiligkreuzstrasse 59,
72379 Hechingen Germany