Thermo Fisher Scientific Inc. is the world leader in serving science, with an annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000+ colleagues deliver an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD

　　As one of the largest biotechnology companies in Germany, we research, develop, and produce innovative biomarker diagnostics and distribute our products in more than 65 countries. B•R•A•H•M•S is based in Hennigsdorf near Berlin, which is home to about 285 of the company’s 550 employees worldwide.

　　Manager (m/f/d) Quality Assurance

　　Region Hennigsdorf bei Berlin

　　In this role, you are leading the QA departments of CDD Biomarkers for the sites BRAHMS GmbH (Hennigsdorf) and Cezanne SAS (Nîmes). You are setting the direction for achieving added value and securing/maintaining compliance according to the Thermo Fisher Scientific Quality Policy and by implementing and performing various QM processes throughout all different departments according to international standards and regulations (ISO 13485, MDSAP, IVDR, 21 CFR 820.

　　Your responsibilities:

　　Setting up the strategy for and ensuring that quality processes are established, implemented, and maintained at all levels within the organization required by the latest valid versions of ISO 13485, MDSAP, 21 CFR 820, IVDR 2017/746/EC, MPDG, and other international standards and regulations.

　　Ensuring by QA organization that adequate quality advice and guidance is provided to all departments.

　　Ensuring training tools are established and training is performed for all employees working within the quality management system.

　　Ensuring processes and compliant infrastructure regarding quality documents and records are established and maintained.

　　Monitoring, evaluating, and reporting the effectiveness of the Quality Management System and its processes regarding suitability, adequacy and efficiency; initiating measures where required.

　　Ensuring that the internal audit concept is established and performed accordingly to yearly planning cycle.

　　Establishment and management of the various key elements of QMS as corrective and preventive action system, deviation process, process regarding non-conforming material and risk management process.

　　Provide strategy for management of Change Control Process to reflect all possible impacts of a change and to enforce to all world-wide compliance aspects.

　　Reporting on the performance of the quality management system and any need for improvements to the Executive Management Team (MTM) twice a year.

　　Your qualifications

　　A minimum Bachelor’s degree is required, preferably in a science or engineering field.

　　Strong experience in a manufacturing environment and with coordinating different quality systems.

　　Sound experience as a people leader.

　　Knowledge and direct experience working with ISO standards and regulations (e.g. ISO 13485, ISO 14971 MDSAP, 21 CFR 820, additional national standards, IVDD/ IVDR).

　　Knowledge of process validation, change control, auditing quality management systems.

　　Skilled at analyzing data and summarizing results, as well as generating performance metrics to drive improvement.

　　Meticulous, organized and accurate; successful with influencing and driving results.

　　Able to prioritize to meet objectives. Strong solution orientation.

　　Strong written and oral communication skills, with the ability to collaborate and communicate effectively both externally and throughout the organization in German and English.

　　We offer

　　Employment with an innovative, future-oriented organization.

　　Outstanding career and development prospects.

　　Company pension scheme.

　　Exciting company culture which stands for integrity, intensity, involvement and innovation.

　　If you are interested, please apply online with your CV and Motivation Letter including possible start date and salary expectations.

　　At Thermo Fisher Scientific, each one of our 100,000+ extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.

　　Apply today! http://jobs.thermofisher.com

　　Agency notice:

　　Please note we are not interested in receiving unsolicited CVs from any personnel service providers. Should you choose to send us or upload any such candidate document they will not be acknowledged and will be deleted in line with our privacy policy.

　　Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.