Quality Assurance Manager
Are you a medical device or clinical lab quality assurance professional? Are you passionate about building impactful QMS processes in a global organization at the forefront of life sciences and healthcare? If you answered yes, this position might be for you.
Blueprint Genetics, a Quest Diagnostics company, is a clinical genetic testing company aspiring to bring genetic knowledge to mainstream healthcare to benefit patients with rare inherited diseases worldwide. We are looking for a Quality Assurance Manager to lead our QA team in Finland.
We are looking for those who want to make a difference
Ability to meet and exceed customers’ expectations is crucial in the growth and success of Blueprint Genetics. Our FINAS (ISO 15189), CAP accredited, and CLIA certified quality management system and its processes have a big role in it. We have also expanded our IVD medical device portfolio and have a permit for a laboratory in the State of New York. As a Quality Assurance Manager at Blueprint Genetics, you will have the opportunity to develop our management system and interact with highly-skilled professionals in an ever-changing field of global genetic testing.
In this role, you will be responsible for the maintenance and improvement of the Quality Management System of Blueprint Genetics Finland. You will ensure our testing and site activities meet our external and internal clients’ needs. You will execute our quality and regulatory strategy and set and drive annual targets. You will monitor KPIs and make fact-based decisions and report results. You will work cross-functionally with all functions including Operations, Product Management and R&D to drive continuous improvement in Europe. You will also get to frequently interact with your counterparts in the US to align local processes with global corporate wide policies.
You will join a small and efficient Quality and Regulatory team in Finland and lead a team of two senior quality assurance professionals. You will report directly to Director, Quality and Regulatory based in Finland. Together you will improve and maintain impactful QA processes and contribute significantly in our global mission to create healthier world, one life at a time.
We hope you can join our office in Keilaniemi, Espoo, but you have the flexibility to work partly remotely as well. This is a full-time, permanent position.
Your main tasks will include:
- Leading the Quality Assurance team and setting performance and development goals
- Developing, maintaining and improving the Quality Management System of Blueprint Genetics Finland in compliance with applicable standards and regulations
- Acting as a clinical lab quality manager as per ISO 15189 and NY CLEP
- Executing our quality and regulatory strategy
- Monitoring key performance indicators, analyzing data and reporting results of QA processes
- Communicating QA/QMS-related matters to personnel and management
- Providing QA training and support
- Representing site’s QA in audits
- Participating in conformity assessment and vigilance processes
- Advancing the quality culture and promoting inspection readiness mindset
Our expectations:
We are looking for a seasoned and sharp team member who is ready to take ownership of the implementation, maintenance and continuous improvement of Helsinki site’s QMS. You want to make a change; you can analyze existing processes and data and identify opportunities for process and workflow improvements. You have self-driven, proactive, and analytical way of working. You are a quick decision-maker, and you can find insightful and practical solutions to daily challenges. We hope you are enthusiastic about being a people lead and working together as a team to achieve common goals. Furthermore, you are well-equipped to work in a rapidly changing, global matrix environment, where ways of working and playbooks are evolving. Last but not least, we aspire to find a colleague who fits the inclusive and international culture of Blueprint Genetics and Quest Diagnostics.
Our ideal candidate would have:
- Bachelor’s or master’s degree in life sciences, engineering or other relevant education
- Solid working experience with medical device and clinical lab quality assurance
- Extensive understanding of applicable regulations and industry standards, inclusive of ISO15189, ISO13485 and IVDR
- Previous people leader experience and ability to set goals, motivate and drive performance
- Good business acumen and international exposure
- Ability to build partnerships and work with people at all levels of the organization and across geographic boundaries to achieve common goals
- Ability to maintain compliance and improve processes through facilitation, teamwork, effective communication and influencing skills.
- Ability to organize long-term project plans and meet assigned targets and deadlines
- Excellent verbal and written communication skills in English and Finnish
- Occasional flexibility with working hours to meet different time zone requirement
What we offer:
- The opportunity to work in a growing company that makes a real difference – Blueprint Genetics has a clear and motivating purpose to improve the lives of patients and families affected by inherited diseases.
- Excellent timing for joining the next chapter of a unique company. Blueprint Genetics was acquired in 2020 by Quest Diagnostics, the world’s leading provider of diagnostic information service. Now is the time to bring best-in-class genetic testing to the global market at scale.
- Hybrid work – we like to see each other in the office every now and then but offer the opportunity to work remotely as well.
- A friendly, flexible and multicultural work environment with great people from different fields of expertise. We are a team of experienced professionals, who collaborate to drive genetic knowledge forward.
- Flexible working conditions and employee benefits such as participation in performance-based bonus payment system, extensive occupational healthcare with Heltti, sports, culture & wellbeing benefit, lunch benefit, team events & office parties.
How to apply
If you are interested in hearing more, please send us your application and CV at the latest on Monday, September 23. Interviews will be started during the application period and the position will be filled as soon as a suitable candidate is found. We hope to hear from you soon!
Who we are:
Blueprint Genetics is a Quest Diagnostics company. Quest Diagnostics, A Fortune 500 company, is the world’s leading provider of diagnostic information services. www.questdiagnostics.com
- Team
- Quality & Regulatory
- Locations
- Espoo, Finland
- Remote status
- Hybrid Remote
Colleagues
About Blueprint Genetics
We are changing diagnostics by providing accessible and actionable genetic knowledge in all medical specialties. Our mission is to support healthcare professionals around the world in providing the best care for patients and families with rare inherited diseases. We do that by delivering answers using fast, affordable, and comprehensive genetic diagnostics.
Quality Assurance Manager
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