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Job ID :
51751BR
Location :
Austria - Remote|Austria - Vienna|Germany - Frankfurt|Germany - Hennigsdorf|Germany - Munchen|Germany - Munich|Germany - Remote / Field|Switzerland - Basel|Switzerland - Remote / Field|Switzerland - Zurich
:
Job Description
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $18 billion and 55,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer.

Our commercial organisations are managing sales and marketing, distribution, import, warehousing, customer services and field service operations for diagnostics medical device products and related industries. The quality management system is based on the requirements of ISO 13485 and ISO 9001.

In order to establish the quality assurance system on a matrix level we are looking for a

Quality and Regulatory Cluster Representative – DACH (m/f)
Region Hennigsdorf bei Berlin

The purpose of this role is to provide operational direction and leadership for driving the successful implementation of one aligned quality management system for our commercial organisation in the region, and then maintain and improve the system. Part of the responsibilities is also to represent the entities in any contact with local authorities responsible for regulation and surveillance of product safety. The person in this role will lead a cluster of countries; Germany, Austria and Switzerland, and report directly into the Cluster Top Manager.

Your responsibilities:

• External and internal audits.
• Quality System Management.
• Regulatory Affairs and Post Market Surveillance.
• Non Conformities and Corrective Actions.
• Management Review and Quality Metrics.
• Trainings on quality system and procedures.

Your qualifications:

• A university degree or equivalent in a relevant technical subject (e.g. chemistry, pharmacy or engineering).
• Quality and compliance knowledge of working with ISO 9001, ISO 13485 and/or FDA 21 CFR 820.
• Significant experience with numerous years of administering quality systems such as complaint management, CAPA, training, etc.
• Experience in supervising or leading teams to a successful outcome is desired.
• Ability to balance compliance requirements with customer requests and offer appropriate advice.
• Capability to lead change and work across departments to implement new procedures and programs in a matrix organization.
• Previous experience from a regulated work environment, preferably within the medical device or diagnostic industry.
• Travels, 10-50%, within the country and region; Germany, Austria and Switzerland, and abroad when required.
• Multilingual, essential ability to speak and write English and German on a professional level.

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.

At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission.

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.

Interested?
We are looking forward to receive your application. Please refer to the above Job ID and include your salary expectations as well as your period of notice.

*IND-EMEA


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