Senior Quality Systems Specialist
- Maastricht
• You are in charge of the overall BRC Quality Management System's suitability, adequacy and effectiveness; • You take the lead in the development and maintenance of quality programs, systems, processes and procedures to ensure the QMS is compliant to ISO13485 and 21CFRPart820; • You promote awareness of applicable Quality Management System requirements throughout the BRC organization; • At least 5 years of experience in a Quality/Regulatory function with a demonstrated focus on Quality Management Systems based on the medical device industry standard ISO13485; • Demonstrated MDSAP and in particular FDA Quality System Regulation (21CFR Part820) knowledge and experience. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced by families and healthcare systems today.
• You are in charge of the overall BRC Quality Management System's suitability, adequacy and effectiveness; • You take the lead in the development and maintenance of quality programs, systems, processes and procedures to ensure the QMS is compliant to ISO13485 and 21CFRPart820; • You promote awareness of applicable Quality Management System requirements throughout the BRC organization; • At least 5 years of experience in a Quality/Regulatory function with a demonstrated focus on Quality Management Systems based on the medical device industry standard ISO13485; • Demonstrated MDSAP and in particular FDA Quality System Regulation (21CFR Part820) knowledge and experience. We believe our deep clinical, therapeutic and economic expertise can help address the complex challenges - such as rising costs, aging populations and the burden of chronic disease - faced by families and healthcare systems today.
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