Global QA/RA Manager, Medical Device, Obstecare

Would you like to contribute to safer childbirths and better maternal care? Do you have experience from QA/RA within ISO 13485? Do you want to be responsible for the quality system in a developing company where you can make an impact?

Today, midwifes and obstetricians are left to subjective and manual judgements for important and time sensitive decisions in childbirths. Obstecare’s diagnostic tool provides maternity ward staff with simple, fast and objective guidance to avoid life-threatening complications for mother and child. With roots in clinical research we are now bringing an updated version of our product to the global market.

As QA/RA Manager in a small and fast-growing company, you will be vital for building, developing and maintaining the quality management system and quality culture. You will work closely with others towards compliance with IVDR, the in vitro diagnostic regulation. You will have a both operative and strategic responsibilities within e.g. risk management, guidance and control of external manufacturers & suppliers, governing documents as well as keeping updated of global regulations.

Are you interested? Here is more information about the job, the company and the product: https://search4s.teamtailor.com/pages/qa-ra-manager-obstecare

Location: Solna.
Terms: This is a full-time open-ended position with Obstecare as employer.
Start: As soon as possible or upon agreement.

Qualifications
Are you ready to be a major part of building and ensuring compliance to IVDR? Would you enjoy the dynamics of a small, fast-growing company? In that case, apply! We think that you fit this profile:

Bachelor or Master of Science in relevant academic field, alternatively extensive practical and theoretical experience in quality and regulatory work
Experience of application of ISO 13485
Practical experience of working with deviations/CAPAs, changes and risk management
Taken active part in internal and/or external audits, as well as supplier evaluations
Professional level of English both orally and in writing, and preferably good level of Swedish

Application and information:
In this recruitment Obstecare is working with Search4S. For more information contact Recruitment Consultant Anna Rennermalm, +46 707 94 20 05 or anna@search4s.se.

Last application date: Mar 14 2021

Interviews and selection of candidates will be continuous. Note that the application should be sent through this link and not by email: https://search4s.teamtailor.com/jobs/1084179-global-qa-ra-manager-medical-device-obstecare

About Obstecare
ObsteCare AB is a provider of medical solutions with a global focus on improving delivery care for both the mother and the healthcare provider. This is done by supplying reliable services and products, facilitating efficient care in maternity wards.

The company was founded on groundbreaking research at the Karolinska Institute, based upon the effect of lactate in the amniotic fluid of delivering mothers. The products originating from the research are the result of more than 20 years of in depth knowledge of the practical situation in delivery wards.

With focus on cutting edge technology, ObsteCare provides innovative solutions helping to improve quality of care during the delivery process. The product line is built on a patented¹ technology and is the only solution available on the market for Point-of-Care use in monitoring lactate in amniotic fluid.

ObsteCare’s vision is to be the market leader in the area of solutions and products for delivery care, for the benefit of the individual patient and the healthcare provider. Through continuous research and development, new solutions will be introduced and existing systems upgraded.

www.obstecare.com (http://www.obstecare.com)