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Quality Engineer (3-5 years experience)
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!
Our client is a professional Medical Devices organization, based in Switzerland.
They are well-known for their electrical medical equipment (class II) and currently looking for a new Quality Engineer due to internal growth.
• Perform more complex quality analyses and inspections, for example data analysis, benchmark testing, localization, and destructive/non-destructive analysis.
• Manage non conformities (related to incoming inspection, in process or final control), lead the Material Review Board for the final disposition, follow-up on related actions and manage the records
• Manage the quality release through the DHR review and approval.
• Evaluate quality data and reports to identify and address recurring problems either with the quality of the product or the reliability of testing procedures. Support the Implementation of the organizations manufacturing processes, systems, and technology and recommend changes that will improve the quality of the organizations finished products.
• Assistance to Quality Manager on: educate, train, and monitor the performance of quality assurance inspectors and other staff to ensure that they understand and comply with established quality procedures and standards.
• Assistance to Quality Manager: educate, train, and monitor the performance of quality assurance inspectors and other staff to ensure that they understand and comply with established quality procedures and standards.
• Manages quality related issues: is technically competent to evaluate design control/product validation activities and data to ensure that design control/validation activities and data are appropriately implemented and utilized to support desired objections and conclusions. Provides audit methodology. Participate in internal or external audits
• Coach and mentor less experienced engineers; check the quality of their work and help them resolve problems. Closely cooperates / interacts with the vendors and suppliers to optimize the flows and controls.
• Other responsibilities according to needs on-site.
• Measuring technique
• Demonstrated ability to learn key products and process knowledge quickly
• Analytical Skills and Statistic methods.
• Quality management systems and methodologies
• Internal client management (not customers)
• Rules and regulatory frames
• Motivation and commitment to results
• Driver of change, propose actively initiatives and innovative solutions
• Experience in medical device operations which enables first-hand knowledge of manufacturing, QC/QA, and regulatory and interface with R&D, Purchasing.
• Bachelor's degree in an applied technical discipline and minimum
• RAC and ASQ certification preferred
• 2-5 years Medical Device experience preferred
• Experience in IEC 60601 highly preferred
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Matthias Kunkel.