Principle Devices 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 and Pharmaceutical organization, based in Noord-Brabant Netherlands.
The company is an international medical device and pharma organisation focusing on improving life saving devices we use in our daily life style. They are currently improving their market and products drastically and therefore are in need of a whole new team, starting with a new Principal Quality Engineer.
ROLE DESCRIPTION
This key role will assist with the design, development, commercialization for the company Mechanical, electro-mechanical devices. As the principal quality you will be highly visible and interacting with management from Europe and US to prepare and conduct regional activities with the devices currently in the market and the future improvements they are focusing on. You will work in Breda, responsible for Europe, but report to the corporate quality director in US. You will have a unique role within a new strategy and project.
RESPONSIBILITIES
As the newest asset you will be responsible for:
• Quality and company procedures: Design Control, Change control, NC/CAPA, risk Management, Validation and manufacturing.
• Ensure development for products such as Mechanical Medical Devices/Digital Health products and software medical devices, diagnostic devices.
• Train and educate colleagues, partners and management on current/new medical device requirements.
• Provide Quality Leadership for European Market
REQUIREMENTS
• A minimum of 5 years of experience in Medical Device environment
• At least 5 years of experience in Quality, Engineering or operations
• Experience with 21 CFR 820, MDD, ISO 13485, IEC 60601 and IEC 62366
• Experience with Computer System Validation and/or Software engineering is a huge plus
• Strong as a people manager and project management
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.
