We are looking for QARA Manager, Instrumentation and Software to join our Quality Management Team
You are an experienced QARA professional who thrives to succeed, enjoy working with internal and external cooperation partners and value good cooperation. Together with the Quality Management team you will be creating quality and regulatory base for our IVD instrumentation and software, as well as for the Aidian computerized systems (CS). You will work closely with internal stakeholders, especially with instrumentation, marketing and IT teams.
In your role you will be responsible for following, interpreting and implementing instrument and software regulations to Aidian's IVD devices and solutions. As a QARA expert you will participate in instrument development, instrument and software registrations and product life cycle maintenance phases. Regulations and standards are at the heart of your work.
Our ideal candidate has:
- experience from design control, technical documentation, PMS, CAPA and risk management
- ability to handle systematically complex entities and make justified decisions
- good communication and collaboration skills to support work in cross-functional teams
- applicable education, e.g. BSc or MSc in engineering or biotechnology
Cybersecurity and connectivity experience as well as registration and auditing skills are considered as an advantage.
What we offer?
We offer you a meaningful work in a professional and well-functioning team. Together with our great colleagues we create high-quality, value-adding and safe products to our customers in a sustainable way. You will have diverse and interesting tasks and responsibilities, and we strongly support the professional development and competence improvement. Taking care of the continuous development of both well-being and skills of our employees is important for us. You can also have impact on your own work and have the possibility to make independent decisions when needed. Our employee benefits are excellent – we care about our employees!
For more information please contact Mervi Ylianttila, VP, Quality Management and Sustainability, 050 330 6095.
Please send your application, CV and salary request to firstname.lastname@example.org at the latest on 16 October 2022.
Aidian – Your Aid in Diagnostics
Aidian (formerly Orion Diagnostica) is a leading Finnish-based IVD company with almost 50 years of experience in diagnostic tests. We provide smart health solutions for point of care. Our aim is to aid health globally by promoting efficient and fluent healthcare. Through our product offering we take part in fighting against antimicrobial resistance (AMR), one of the biggest threats to global health, and provide solutions to drive sustainable use of antibiotics in primary care. For achieving this we want to create and develop innovative solutions and ways of working. We have approximately 300 dedicated employees who want to be in the forefront of creating tools for better healthcare. Over 90% of our net sales comes from international sales.