(1-2 positions) 

Are you our next Quality Maker? We are seeking quality and regulatory experts with wide and at least 3-5 years’ experience in medical device industry in relevant positions to join Labquality in permanent, full-time positions. Join and enhance our team of medical device experts, providing services to all economic operators in the industry and clinical laboratories. Our services address both quality and regulatory needs throughout the entire lifecycle of medical devices and our customers’ quality management system. 

The nature of the work is diverse and impactful, ranging from large project entities such as commercializing a new product or establishing a quality management system to smaller projects like clinical evaluation or internal auditing. Our satisfied customer base includes large established global players, start-up companies, and everyone in between. 

We offer a varied and responsible set of tasks within Finland's leading expert organization focusing on social and healthcare quality. The extensive experience and expertise of our team members ensure a strong local support network and a platform for discussions in an ever-changing and developing operating environment. You will have the opportunity to collaborate with friendly and professional colleagues, providing high-quality services in our field. 

Your responsibilities and tasks include, for example: 

• Building, maintaining, and developing customers’ Quality Management Systems 

• Regulatory planning and world-wide device registrations,  

• Conducting gap analyses of technical documentation and quality management systems,  

• Creating and updating of, or assisting customers with medical device Technical Documentation, such as biological safety evaluation, usability engineering file, risk management file, electrical safety documentation, software lifecycle management documentation, and clinical/performance evaluation 

• Ensuring fulfilment of design control requirements during medical device development projects 

• Auditing and providing training 

• External roles in quality and regulatory functions 

We hope you have: 

• Strong expertise in medical devices and quality and/or regulatory affairs including experience in ISO 13485, ISO 14971, MDR/IVDR, and/or FDA requirements 

• Specific experience in medical device software, IVDs, or invasive medical devices is preferred 

• University or higher education degree (MSc. or PhD.) on a relevant field of science or engineering 

• Excellent organizational, communication, and problem-solving skills 

• Positive service attitude and mindset for learning new technologies 

• Ability to handle multiple tasks simultaneously and work independently 

• Fluent proficiency in both Finnish and English (spoken and written) 

• Additional professional language skills, such as German or Swedish, are considered an advantage. 

What we offer: 

Join Labquality - a rapidly growing and modern company! Our employees enjoy extensive autonomy and the opportunity to shape the direction of their tasks. We support the balance between work and leisure through flexible work arrangements (including remote work and flexible working hours). We offer a salary commensurate with your expertise and work experience. We want to discuss the salary with you, so please provide an estimate of your salary expectations on the application form. In addition, we provide a comprehensive benefits package (including cultural and sports benefits through Smartum, health insurance, and a phone benefit). 

The workplace is located according to your preference, for example, in our offices in Helsinki, Tampere, Turku, Oulu or Kuopio (possibility for remote work). We offer modern office spaces and a pleasant working environment. At Labquality, you become part of a collaborative and approachable team! 

Please fill out the application and submit your CV along with your salary expectations through the application form by no later than August 15th, 2024. 

Additional information: 

For more information about the position, please contact Mika or Terhi: 

 
Mika Siitonen, Head of Digital Health 
mika.siitonen@labquality.com 
+358 50 381 2757  
NOTE! Phone inquiries only during the following hours: July 9th and 11th (2-3 pm.) & August  14th (10-11 am.) 

Terhi Heikkinen, Head of QARA, MD&IVD 
terhi.heikkinen@labquality.com 
+358 9 8566 8250 
NOTE! Phone inquiries only during the following hours: July 30th (3-4 pm.) & August 7th (2-4 pm.) 

We conduct interviews during and after the application period and fill the positions as soon as we find suitable candidates. Please fill out the application and submit your CV along with your salary expectations through the application form by no later than August 15th, 2024.