Interim QA/RA Specialist
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Noord-Holland Netherlands.
• Develop and maintain the Quality Management System to fulfil the ISO 13485 requirements and Company requirements
• Report directly to the QA/RA Central Region Manager.
• Deploy EMEA/Corporate processes and procedures within the organization
• Write appropriate procedures and maintain the Quality Management System document control
• Support and perform internal audits
• Handle Quality issues and complaints, and actively support product surveillance
• Manage instructed recalls and Field Actions, in collaboration with Management of Operations
• Establish good relationships with the local Competent authorities
• Provide required monthly reports to EMEA Management
• Participation at local association meetings.
• Occasional involvement in special projects and special duties.
• B.S. degree in engineering, science, management or equivalent experience.
• Good knowledge of Quality Management system requirements, ideally in medical device industry in Europe.
• Knowledge of legal and regulatory requirements applicable to medical devices
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Fernand Voortjes.
The Company
Their innovative environment gives not only opportunities to develop in personal and professional expertise, but will give as well the opportunity to work with life changing products and provide a service to patients that are in need of these services.Role Description
• Ensure product Quality and Regulatory compliance in country distribution subsidiary• Develop and maintain the Quality Management System to fulfil the ISO 13485 requirements and Company requirements
• Report directly to the QA/RA Central Region Manager.
Responsibilities
• Further development and maintenance of the existing Quality Management System• Deploy EMEA/Corporate processes and procedures within the organization
• Write appropriate procedures and maintain the Quality Management System document control
• Support and perform internal audits
• Handle Quality issues and complaints, and actively support product surveillance
• Manage instructed recalls and Field Actions, in collaboration with Management of Operations
• Establish good relationships with the local Competent authorities
• Provide required monthly reports to EMEA Management
• Participation at local association meetings.
• Occasional involvement in special projects and special duties.
Requirements
• Knowledge of Risk Management, ISO 13485, MDR, MDD• B.S. degree in engineering, science, management or equivalent experience.
• Good knowledge of Quality Management system requirements, ideally in medical device industry in Europe.
• Knowledge of legal and regulatory requirements applicable to medical devices
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Fernand Voortjes.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
