Quality Management Systems Manager
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
is a developer of all sorts of Medical Devices on a global level.
ROLE DESCRIPTION
My client is looking for an enthusiastic contingent worker in the area of Management Review, Corrective Action and Preventive Action (CAPA) and Record control with experience in Business Quality Management Systems (ISO 13485) and FDA (21CFR) regulations within an international environment. The team consists of 8 professionals with activities like Quality Management, System Validation, CAPA and Management Review and Change, Doc & Rec Control.
RESPONSIBILITIES
• Manages Q&R processes CAPA Management and Management Review to ensure process ownership for all activities under the Consumer Lifestyle (CL) Personal Health Businesses governance.
• Effective Subject Matter Expert for Record Control and tools for Philips Q&R.
• Develops and revises draft Record Control standards for (non-)medical products/solutions.
• Provides leadership direction to Business personnel on understanding, interpretation and implementation of standards and regulations related to Record Control.
• Recommends standards strategy to support Philips mission, vision, and strategy.
• Ensures Q&R requirements are effective in all processes in scope.
REQUIREMENTS
• BA/BS degree.
• CMII certification (or other equivalent configuration management certification) preferred.
• Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Minimum of 6 years of related experience in Record Control and CAPA management field
• Minimum of 4 years of experience in Business Quality Management Systems (ISO 13485) and FDA (21CFR) regulations
• Familiarity with Document Management System tools
• Experience running effective process improvement projects
• Knowledge of Applicable regulations (Quality System Regulations) and regulatory requirements
• Strong focus on customer service
• Preferred Qualifications:
o Engineering background.
o Procedural or Technical writing experience.
o Understanding of modeling tools.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.
