(Senior) Quality Engineer

Location: Netherlands

SIRE 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 innovative devices that support health care and hospitals. They thrive in a passionate working environment, dedicated to develop and distribute their devices to 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 world.

ROLE DESCRIPTION

Your position will be focused on participating in the development and maintenance of a robust quality system in compliance with all relevant standards and regulations. Utilise quality system processes to support corporate objectives and continually improve the effectiveness of the quality system. Here you will fulfil with your team a central and visible role to guarantee the improvement of the Medical world around you.

RESPONSIBILITIES

They main responsibilities that you will have as a (Sr.) Quality Engineer are, but not limited to:
• 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.