For our client, one of the worldwide leading manufacturers of measuring instruments and test
assays for clinical diagnostic and life science, we are currently looking for this permanent position in Munich:
Manager Quality Assurance (f/m)
- You ensure compliance of the products and the design process, including design changes to established products.
- You lead a team of quality engineers supporting Automation and Informatics product lines.
- You interact collaboratively with the Product Compliance Group, to ensure the type testing certification such as electrical and electromagnetic compatibility and also compliance to product specific directives such as restriction of Hazardous Substances (RoHS) are in place, and with the Development Group to make sure that applicable standards are met (such as Software development lifecycles and Usability engineering).
- You are able to work in a matrix and multicultural environment to drive improvement and simplification.
- Thanks to your vision of Quality in a regulated environment you are able to inspire and develop your team and to influence stakeholders in order to improve processes and maintain compliance.
- Specific Responsibilities:
- Leading and developing a team of Quality Engineers
- Ensuring Design Control compliance
- Driving Design Validation and non-product software validation
- Coordinating Risk Management activities
- Driving improvement of local and global processes associated to design and development
- Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
- Successful experience in leading a QRA team in Medical device/IVD industry of 10 years +
- Excellent communication skills and team work
- Excellent practical experience of ISO9001, ISO13485and 21 CFR part 820 Quality System Regulation
- Experience in design validation and generation of associated protocols gained either from in house testing, simulating end use or actual end use in a clinical environment
- Computer skills (MS Office products)
- Knowledge of ISO14971, IEC 60601 / IEC 61010 3rd Edition, IEC 62366 and IEC 62304.
- Ability to work cross culturally/functionally and understand functional department requirements
- Proficient in English
- Excellent organizational capabilities
- Highly ethical, you are able to multi-task and prioritize in a competitive environment
- Clean driving record ? ability to travel as required (may include international travel).