Could you be the Quality and Compliance Manager we are looking for? 

To ensure high-quality software products for our clients in the healthcare industry is at the heart of what we do. Read on for more details and seize this opportunity: 

Detailed information about your role 

We seek for an experienced and hands-on-oriented Quality and Compliance Manager to lead our quality management and compliance initiatives and operations. In this role, you maintain our capability for quality, safety, and regulatory adherence, while supporting the development and release of innovative software solutions for healthcare diagnostics. You will report to the Chief Technology Officer. 

Here are your key responsibilities, divided into four major themes: 

ISO 13485-compliant Quality Management System (QMS): 

• Lead and maintain the implementation of the existing ISO 13485-compliant QMS across all company functions. 

• Serve as the QMS management representative. 

• Oversee internal and external audits to ensure compliance with ISO 13485 and other relevant standards. 

• Manage document control processes, including creation, review, approval, and archiving of QMS documentation. 

• Develop and implement quality objectives, metrics, and performance monitoring systems. 

• Facilitate management reviews to evaluate the effectiveness of the QMS and identify areas for improvement. 

• Oversee the conductance of root cause analyses and management of corrective and preventive actions (CAPAs). 

Regulatory Compliance: 

• Ensure compliance with all applicable medical device and cybersecurity regulations and standards (e.g., EU IVDR, ISO 27001, EU NIS2). 

• Act as the primary contact for regulatory authorities for audits, inspections, and submissions (e.g. Valvira, Fimea). 

• Serve as PRRC (Person Responsible for Regulatory Compliance) and DPO (Data Protection Officer). 

• Oversee the creation and maintenance of technical files and regulatory submissions. 

• Monitor changes in medical device and cybersecurity regulations and update company processes accordingly. 

• Coordinate risk management activities in accordance with ISO 14971. 

• Support software development teams and other participants in software lifecycle processes to ensure compliance with IEC 62304 (Medical Device Software Lifecycle Processes). 

Assurance of and Continuous Improvement in Quality and Compliance: 

• Collaborate with cross-functional teams to embed quality and compliance best practices across all functions and especially within the software lifecycle processes. 

• Conduct quality training for employees to ensure awareness and adherence to regulatory requirements. 

• Oversee customer complaint investigations, including root cause analysis and resolution. 

• Drive initiatives for continuous improvement in quality processes and workflows. 

Team Lead for Quality and Compliance Team:  

• Lead, guide, and develop our Quality and Compliance Team. 

While your role is independent and responsible, you are not alone. Success is a collective effort. You will be welcomed by a skilled group of colleagues who are eager to learn and collaborate to create high-quality and reliable software products. 

Are you a quality management professional with experience in healthcare or other strictly regulated software environments? 

If so, this role might be perfect for you. To succeed in this position, you need a minimum of 5 years of experience in quality management within a healthcare or other strictly regulated software environment. 

We specifically value proven experience with ISO 13485 QMS implementation and maintenance. Strong knowledge of medical device standards, including ISO 13485, ISO 14971, and IEC 62304 is essential. Familiarity with EU MDR/IVDR medical device regulatory requirements, ISO 27001 ISMS implementation and maintenance, and EU NIS2 cybersecurity regulatory requirements is also highly valued. 

You have a Bachelor’s or Master’s degree in Engineering, Quality Management, Life Sciences, or a related field. 

In this role, you need excellent leadership and managerial skills, with the ability to inspire and motivate healthcare software professionals. Your leadership approach should combine courage, curiosity, and a strong vision with the ability to work on the front lines on quality and compliance matters when necessary.  

You must be an effective communicator and possess cross-functional skills to liaise with internal teams, regulatory authorities and other external stakeholders. We hope you have a high level of persistence and professional pride in driving quality and compliance initiatives and operations. 

In this role, fluent spoken and written proficiency in Finnish and English is required. Proficiency in other Nordic languages is beneficial. 

Good work and good life 

For us, a good life doesn't just mean good work. We believe in meaningful work, strong professionalism, good collaboration, and taking care of our well-being. These values are supported by comprehensive employee benefits that our employees highly appreciate. 

Working at Mylab is described by our people as flexible, recognizing that life is not the same for everyone. We prioritize the well-being, success, and professional development of our employees. 

While we usually work where it suits us best, including remote work, it's always nice to drop by our Tampere office occasionally—to meet colleagues, advance projects, and exchange updates. 

Could you be the new colleague we are looking for? 

We hope to find a colleague for this permanent position soon. The salary range for this position is €5600–€6200/month. 

You can apply to be our colleague until January 31, 2025, by sending your application, CV, and salary request through the link below. We will review applications and interview those interested in the position already during the application period. So, don't hesitate to apply if you are intrigued by this opportunity. 

If you have questions about the position, working with us, or the recruitment process, Chief People and Culture Officer Karoliina Hälli will be happy to discuss them with you. Please call +35810 6786110 on Mon 20th or 27th on the received call hour 14:00-15:00. You can also reach out via email at karoliina.halli@mylab.fi or recruitment@mylab.fi. 

We hope this position caught your interest. It would be great to have the opportunity to get to know each other better!