Tel:(+46 735 079993)
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Do you want to work at one of Sweden’s hottest and fastest growing start-up companies? Natural Cycles is all about combining scientific research and mobile tech to empower every woman worldwide with knowledge about her body, menstrual cycle and fertility. This is your chance to become a part of their exiting journey!
Natural Cycles is a revolutionary approach to birth control and family planning, empowering women to take informed decisions. Developed initially by two former physicists, their algorithm and app is clinically tested, used by more than 900 000 registered users and they are backed by several international VC firms. Natural Cycles is located in the center of Stockholm, have a great familiar atmosphere and they are a truly diverse workplace with more than 30 nationalities and 60/40 in gender diversity. Natural Cycles currently have users in over 160 countries across the world, with the headquarters in Stockholm.
Natural Cycles is one of Stockholm's hottest startups and the world's leading startup in the area of contraception and reproductive health. Besides providing women with a life-changing tool to monitor their fertility, the application is also a unique research platform yielding exciting new clinical data on a regular basis.
We are looking for a Quality System Manager who is passionate about compliance and contributing to establish an internal culture of improvement and QMS involvement with a focus on efficiency and simplicity, creating internal structures that give value to the different departments and the way of working.
You will be responsible for the Quality Management System structure and its continued compliance including gap analysis towards new or updated regulatory requirements, as well as lead interpretation and implementation activities. You will answer for adapting the Quality System with continued growth of the organization.The role also includes responsibility for the Quality System improvements and identifying and implementing necessary interfaces between different departments and sites. You will work with Quality functions and tasks within the QMS, including updating the Quality Manual and owning the Document Control process.
Further examples of responsibilities:
-Lead the completion and maintenance of risk analysis related to quality systems
-Manage and perform internal and mock audits
-Support investigations, and resolve Quality System non-conformities (defined during internal and/or external audits)
-Responsible for that Quality Agreements are kept up to date
-Work with all departments in order to make sure the way of working are reflected in the QMS when applicable
-Give necessary training internally regarding the QMS
-Report your actions and results.
-Experience of a strictly regulated business environment is essential (e.g. Regulatory affairs, Medical Device, Clinical, Medical, Pharmaceutical)
-Experience in Medical Device Directive 93/42/EEC is preferred
-Experience in ISO 13485, QSR and ISO 14971 is essential
-Successful experience in redesigning and implementing a QMS in a global organisation
-Demonstrated understanding of business need versus compliance
-Good project management skills
-Excellent English, verbal and written
- 5 + years of experience within the field
As we have customers and employees from all over the world, it is very important that you are free from prejudices against different cultures, religious views or ethnicities.
Sounds interesting? Good because it really is! Click “Sök jobbet” below to apply. In this recruitment Natural Cycles is working with Skills & Talent AB. For further information or questions, please contact Recruitment Consultant Eric Öholm at email@example.com.
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