Thermo Fisher Scientific Inc. is the world leader in serving science, with 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 productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our team of more than 100,000 colleagues delivers 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. Location/Division Specific Information Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees. Discover Impactful Work: The Quality Manager (m/f/d) is responsible for ensuring compliance to regulatory requirements and standards applicable to the medical device and in vitro diagnostic industries as relevant for all markets being served. This position oversees and directs quality systems/compliance activities, provides quality management guidance to the entire site, as well as manages the QM team (poeple management of 10 team members). The position reports to the Director Global Quality Assurance and serves as a key business partner, working closely with the entire organization to ensure compliance and product quality A day in the Life: - Ensure compliance with medical device and in vitro diagnostic regulations and standards. - Be the ambassador for continuous improvements of product quality and services. - Improve the customer experience regarding initial quality and long- term reliability by leading quality related cross-functional collaboration throughout the life cycle management process. This will involve strong cross functional skills to arrive at the most effective execution of the Quality System. - Assure proper communication and site-wide training related to regulations applicable to the medical device and in-vitro diagnostic industries. - Manage, audit, analyze and propose improvements in the Quality Management System. - Lead and manage external inspections, e.g. from Competent Authorities, Notified Bodies, customers and other third-party Quality System evaluations. - Author, change and update the Quality Manual, QA procedures and instructions in alignment with divisional procedures and instructions as applicable. - Assure the QM-teams involvement in divisional Quality System initiatives. - Assure timely and efficient implementation of divisional Quality System procedures, instructions and tools. - Maintain up-to-date knowledge of all applicable regulations, guidelines, and standards. - Conduct Quality Management Reviews, ensuring periodic cross-functional evaluation of quality metrics and implement corrective actions against adverse trends and non-conformances. - Have the role as Management Representative. Keys to Success: Education - A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by an EU Member State, in law, medicine, pharmacy, engineering or another relevant scientific discipline. Experience - Significant experience from quality management systems in an IVD/Medical device environment, e.g. QSR, EU IVD Regulation, ISO 13485, ISO14971, etc. - Many years in a medical regulated industry with experience in a management position, including personnel and budget responsibilities. - Senior experience in managing external inspections from competent authorities and notified bodies. Knowledge, Skills, Abilities - Excellent verbal/written communication skills; fluency in German and English preferred. - Coaching Leadership style with ability to set clear direction and delegate authority. - Being a role model leader in developing and motivating people at all levels. - Proven ability to adapt to changing organizational and operational needs and the ability to lead others through change. - Strong team player and leader with the ability to work across multiple functions and disciplines. - Creating an energetic and forward-looking environment. - Ability to create a strong quality culture, fostering integrity. - Build trustful and strong networking relationships. - Creative, with analytical problem-solving skills. What we offer: - Employment with an innovative, future-oriented organisation - Outstanding career and development prospects - Company pension scheme and other fringe benefits - 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 Join us and contribute to our singular mission—enabling our customers to make the world heal() Die Stellenbeschreibung kann nicht vollständig angezeigt werden. Bitte folgen Sie dem u.a. Link 'Weitere Informationen zum Stellenangebot im Internet'
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