Quality System Manager
Regulatory & Compliance – Stockholm
Natural Cycles is looking for a Quality System manager!
-Fluency in English required-
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.
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.
What you will be doing
- 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
- Responsible for adapting the Quality System with continued growth of the organization including globalization
- Responsible for the Quality System improvements and identifying and implementing necessary interfaces between different departments and sites.
- Responsible for Quality functions and tasks within the QMS, including updating the Quality Manual and owning the Document Control process
- 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.
Natural Cycles currently have users in over 160 countries across the world, with the headquarters in Stockholm.
You will be working full time with us on location in our office in Stockholm.
Who you are & What skills and experience you should have
- 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 prefered
- Experience in ISO 13485, QSR and ISO 14971 is essential
- Successful experience in redesigning and implementing a QMS in a global organisation
- 5+ years experience in Quality Assurance and Management
- Demonstrated understanding of business need versus compliance
- Good cross functional leadership skills
- Good project management skills
- Strong influence, organisational and communication skills
- Motivated, proactive, independent, flexible and adaptable
- Ability to thrive in a dynamic, fast-paced work environment
- Ability to work under pressure and within time constraints
- A pragmatic, communicative person who can see the big picture and is good at finding solutions
- Excellent English, verbal and written
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.
About Natural Cycles
Natural Cycles is a revolutionary approach to birth control and family planning, empowering women to take informed decisions. Developed initially by two former physicists, our algorithm and app is clinically tested and backed by several international VC firms. Natural Cycles is located in the center of Stockholm, have a great familiar atmosphere and we are a truly diverse workplace with more than 30 nationalities and 60/40 in gender diversity.
Only applications in English and submitted through Skills and Talents will be considered.