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Quality Assurance Director
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 Basel-Landschaft Switzerland.
Specializes in the research, development, manufacturing and commercialization of medical devices class III (implantable, active).
Currently looking for a Quality Director who will be responsible for the quality of the product and the quality management system intended to supply evidence of compliance to the guidelines and safety of the product. Accomplished by leading and managing strategic and operational performance of the Quality department, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to regulatory compliance. Ensure the safety of the patient by ensuring the quality of the product and its method of manufacturing.
The company we are talking about is a small company that experienced large growth in recent years. As such there is a considerable amount of updates required to the current QMS. The role of Quality Director will therefore require a strong project oriented skill set to compliment the quality related knowledge as well as the ability to think outside the box, comprise creative and pragmatic solutions whilst adhering to regulatory compliance.
- Final release of the product ensuring compliance with defined specifications.
- Maintain the QMS to meet state of the art guidelines.
- Act as the main point of contact on all Quality matters, internally and externally.
- Act as the Management Representative in accordance with the requirements of ISO 13485.
- Updating the technical documentation in response to post market feedback, including product complaints and adverse events.
- Report adverse events in accordance with defined timeframes ensuring compliance with regulatory requirements. Represent the company at inspections and audits performed by competent authorities and customers.
- Maintain relation with the notified body and acts as the first point of contact for competent authorities.
- Scientific degree (in engineering, quality management or life sciences)
- Well experienced with Quality Management System design and management
- Strong knowledge of both ISO and GMP regulations
- Qualified Lead Auditor for ISO 13485 or ISO 9001
- Strategic thinker with the ability to influence at a senior level
- Strong leadership/team management skills and experience
- Credible and confident communicator (written and verbal) at all levels
- Highly customer focused
- Excellent project management skills
- Hands-on approach, with a “can do” attitude
- Fluent in German and English is a must
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.