Quality Assurance Manager

Are you a medical device or clinical lab quality assurance professional? Are you passionate about maintaining and improving

impactful 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 an experienced Quality

Assurance Manager to lead our QA team in Finland and continuously improve our quality management system and its processes.

This is a unique opportunity to work at the intersection of clinical laboratory operations and medical device manufacturing,

ensuring the highest standards of quality, compliance, patient safety and meeting customers’ expectations.

Blueprint Genetics is both a FINAS (ISO 15189) and CAP accredited, CLIA certified and NY permitted laboratory and a manufacturer

of IVD medical devices. The laboratory also supports pharmaceutical companies in clinical trials.

The Quality Assurance Manager is responsible for maintaining and improving our Quality Management System (QMS) across both

laboratory and medical device operations. The role ensures continued compliance with ISO 15189, CAP, NY CLEP, ISO 13485, IVDR, and

applicable regulatory requirements while fostering a culture of quality and continuous improvement throughout the organization.

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 and closely with all functions including Blueprint Genetics’ organization and laboratory leadership,

Regulatory Affairs, Product Development and Operations to ensure quality is embedded across all business processes. You will also

get to frequently interact with your counterparts in the US to align local processes with global corporate wide policies and

initiatives.

You will join a Quality and Regulatory team in Finland and lead a team of three quality assurance professionals. You will report

directly to Director, Quality and Regulatory Affairs 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.

• Developing, maintaining and improving the Quality Management System of Blueprint Genetics Finland in compliance with applicable

standards and regulations

We are looking for a seasoned and sharp team member who is ready to take ownership of the implementation, maintenance and

continuous improvement of Blueprint Genetics’ 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.

• 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.

• 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.

• 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, sports, culture & wellbeing benefit, mental wellbeing with Auntie, on-site gym membership, team events

& office parties.

If you are interested in hearing more, please send us your application and CV at the latest on Sunday, August 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!

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