Sr Quality Assurance 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 Noord-Brabant Netherlands.

is the global leader in medical innovations for heart disease, as well as critical care and surgical monitoring

ROLE DESCRIPTION

You will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize internal and external device manufacturing and device distribution. Other important activity is to develop and implement quality systems for all activities linked to warehousing and Distribution at an EMEA level.

RESPONSIBILITIES

· Investigate complex manufacturing product quality and compliance issues for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports
· Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve manufacturing processes/methods (including evaluation of source materials and suppliers) and based on engineering principles; analyze results, make recommendations, and develop reports
· Identify and ensure the optimization of complex Manufacturing processes using engineering methods for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc., to improve manufacturing processes, and reduce risk
· Develop, update, and maintain technical content of risk management files
· Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
· Lead Auditor regarding quality compliance audit of 3PLs as well as suppliers and Distributors and monitor status and progress of Supplier Corrective Actions

REQUIREMENTS

· Master's Degree in Engineering or Scientific field
· Approx. 5 years of previous experience in a regulated environment, required
· Knowledge of ISO13485 and FDA CFR 820, LEAN, Six Sigma
· Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
· Working knowledge and understanding of statistical techniques
· Previous experience working with lab/industrial equipment required
· Fluent in English is required, knowledge of Dutch is preferred
· Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
· Strong problem-solving, organizational, analytical and critical thinking skills
· Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

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.