In this role, you work in an organization with an ambitious approach to quality management and continuous development in a global setting. As part of our Quality team, your main responsibility is to lead and ensure the compliance of our quality management system and processes, including ISO 13485 and MDR compliance, while driving continuous improvements in our operations.

What we are looking for

We are searching for a hands-on quality professional with solid experience in medical devices and quality management. We expect you to have expertise in ISO 13485, MDD, MDR, or IVDR. Experience in FDA regulation is advantage. Previous involvement in CAPA and change management processes, as well as internal and external audits, is essential. Experience in managing quality systems in regulated industries is highly valued as well as experience in medical device product lifecycle.

At CardioSignal, we offer you purposeful work and the opportunity to grow with the company and the quickly evolving field of digital health and remote cardiac care. To succeed, you should be solution-oriented and possess a collaborative, proactive mindset.

What you will do

• Ensure that the products and services (mainly softwares) provided by Precordior are fit for purpose, consistent, and meet external and internal requirements, including legal compliance and customer expectations.
• Coordinate activities required to meet quality standards.
• Monitor, document, and advise on the performance of the quality management system, including producing data and reporting on performance against standards.
• Lead and ensure ISO 13485, MDR and FDA regulation compliance of our medical device products.
• Collaborate with multinational teams to develop and improve quality processes that ensure the safe and effective delivery of medical software to customers.
• Manage and maintain quality administration processes, including customer complaint handling, non-conformance reports, CAPA reports, supplier evaluations, and change control requests.
• Perform risk management activities according to ISO 14971.
  
• Conduct internal audits and act as the lead auditor.
• Support external audits, including preparation and execution, and act as a liaison with external regulatory bodies.
• Mentor and support the Quality team in implementing and maintaining QMS processes.

What you will need

• A minimum of a master’s degree in a technical or natural science field, law, or another relevant area.
• Proven experience in quality management for medical devices in accordance with ISO 13485.
• Excellent communication skills in English (both verbal and written), as our company language is English.
• Experience with Jira and Confluence is an advantage.
• A solution-driven mindset and the ability to take initiative.
• While remote work is supported, this role requires regular, yet not weekly, presence at our Turku office to ensure seamless collaboration and alignment with the team. Therefore the employee should be based in Finland.

What we offer

• Purposeful work: Contribute to meaningful projects in the healthcare sector.
• Fantastic team: Join a multidisciplinary team of professionals dedicated to making an impact.
• Modern tools: Access to the latest technologies and work equipment of your choice.

How to apply for this job

Send us your CV with a cover letter through our career portal. Please note, that applications will only be accepted through our career portal to ensure an efficient and standardized recruitment process. 

For more information about this role, contact our Head of People, Iisa Mattila, via email, iisa.mattila@cardiosignal.com.

Apply by January 1st, or as soon as possible, as we will review applications on a rolling basis.

About CardioSignal

We develop groundbreaking solutions for the detection of heart diseases with digital cardiac biomarkers. The CardioSignal technology utilizes the motion sensors of a smartphone to non-invasively measure cardiac motion and function. Today, the CardioSignal application is available in 15 countries. Originally an academic spinoff, the company’s patented technology is built on a decade of research and algorithm development. CardioSignal is a brand and a product by Precordior, a health technology company based in Finland and the United States. www.cardiosignal.com