As interim people manager in relation to your QA/RA department
As project manager for cross functional activities
Assist you in setting up the frame for your Quality Management Systems: Document Control, training, Non-Conformities, CAPA’s, Customer Complaints, Change Management, Internal audits, Quality Management Review etc.
In relation to Quality measurements, assist you in defining what to measure and how to show associated trending
Assist you with development and implementation of specific lean Quality Processes, incl. development of procedures, instructions and templates
In relation to your products I can assist you with interpretation of regulations and standards, i.e. EU-MDR, MDD, ISO 13485, 21 CFR part 820 (FDA) related to Quality Management Systems for medical devices
I can help you manage preparations for, and hosting of external audits and inspections from authorities and notified bodies incl. management of follow up activities, should you get findings…
I can assist you with some Regulatory Affair activities, i.e. including review of risk management files and IFU’s
In relation to suppliers, I can assist you with Quality Agreements, setting up supplier audit programs, trending of supplier performance etc.
Education and coaching of staff within Quality Assurance and development of courses in line with your specific business needs