Director, QA

at  Radiometer

In our line of work, life isn’t a given - it’s the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we’re located. Creating impactful innovations like ours, doesn’t happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.
At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.Radiometer is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.
The Director QA for Radiometer is responsible for ensuring that our products meet the highest standards of quality and safety what involves managing the QA team, developing and implementing quality control processes, and ensuring that all relevant regulatory requirements are met.
This position is part of the Quality Department located in Turku and will be hybrid position.
You will be as well a part of the Global RAQA team and report to the Sr QA Director responsible for European Operations Quality in Radiometer. If you thrive in a leadership role and want to work to build a world-class QA Team - read on.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Multiple years (+5y) of experience in QA leadership role.
• Thorough understanding of regulatory requirements of IVD industry, especially IVDD/IVDR, ISO 13485, FDA 21 CFR Part 820
• Strong knowledge in quality management systems applicable to medical device or IVD industry
• Ability to apply standards & regulations into practice
• Knowledge of design control and IVD products
• Project management principles, tools and metrics
• Language requirements: Finnish, fluent English skills
• Personal qualifications; leadership skills, teamwork and related interaction skills, negotiation and agreement construction skills, creativity and problem solving skills

IT WOULD BE A PLUS IF YOU ALSO POSSESS PREVIOUS EXPERIENCE IN:

• Deep knowledge of production processes and technologies
• Main principles, methods, technologies and tools of immunoassays; especially TR-FIA assays
• Understanding of customer needs and processes; especially clinical and laboratory practices
  At Radiometer we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Radiometer can provide.

• Ensure compliance of RTKU QMS with all relevant authorities regulatory requirements (ISO/IVDD/IVDR, MDSAP, FDA/QSR) and in line with corporate strategy and policy
• Manage, lead, and mentor the Quality department team.
• Reporting to top management on the effectiveness of the quality management system and any need for improvement
• Ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
• Initiate and support development of effective management systems, procedures and metrics utilizing global approach and corporate practices.
• Member of site management team in leading the site
• Member of global RA/QA management team to drive an efficient global RA/QA organization