Sr. Quality Engineer
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 Limburg Netherlands.
They are a manufacturer and distributor of new innovative devices that support health care and improve the Medical Industry around the world. Due to growth they are looking for a new (Senior) Quality Engineer who is able to make the next step and wants to make an impact on the Medical world.
ROLE DESCRIPTION
Support the development and maintenance of a robust quality system in compliance with all relevant standards and regulations. Utilize quality system processes to support corporate objectives and continually improve the effectiveness of the quality system.
RESPONSIBILITIES
• Responsible for compliance with applicable Corporate Policies and procedures.
• Work with all functional areas to ensure that the quality system is effectively implemented and maintained in compliance with relevant standards and regulations.
• Initiate and manage improvement and development projects regarding quality system improvements, change management, qualifications, validations and risk assessments.
• Initiate, review, update and approve quality system documents as needed.
• Review, analyse and report quality system data to identify trends and identify the need for corrective and preventive actions.
• Provide quality system training including CAPA for the organisation including field staff and field reports, distributors and 3rd party service organisations.
• Support the organisation in order to ensure full compliance to field-based processes.
• Manage Corrective & Preventive Action (CAPA) System
• Manage Audits
• Quality Operations support
• Post Market Surveillance support
REQUIREMENTS
• Bachelor’s degree or equivalent in engineering/science or a combination of education
• Experience in quality management- and environmental management systems, preferably minimal 3 years of experience in a medical device company.
• Demonstrated knowledge ISO13485 and EU MDD93/42/EEC.
• Good knowledge of the English language and German language as a big plus
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jeroen Evertsen.
