Quality Assurance Manager

Blueprint Genetics; Espoo; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work schedule

Performance-based bonus

Job summary

Blueprint Genetics, a Quest Diagnostics company, seeks a Quality Assurance Manager to lead the QA team in Finland and continually enhance the Quality Management System for both laboratory and medical device operations.

The role ensures ISO 15189, CAP, NY CLEP and IVDR compliance while aligning QA with global policies. Hybrid work in Espoo with occasional remote work is offered.

Qualifications

• 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, incl. 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 across geographic boundaries.
• 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.

Responsibilities

• Lead the Quality Assurance team and set performance and development goals.
• Develop, maintain and improve the Quality Management System of Blueprint Genetics Finland in compliance with applicable standards and regulations.
• Act as a clinical lab quality manager as per ISO 15189 and NY CLEP.
• Execute our quality and regulatory strategy.
• Monitor KPIs, analyze data and report results of QA processes.
• Communicate QA/QMS-related matters to personnel and management.
• Support functions and projects in QA matters.
• Provide QA training.
• Represent site’s QA in audits.
• Participate in conformity assessment and vigilance processes.
• Advance the quality culture and promote inspection readiness mindset.

Skills

QA leadership

Regulatory knowledge

Stakeholder collaboration

English & Finnish

Project planning

Problem solving

International exposure

Education

BSc/MSc in life sciences

Engineering degree

Job description

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.

We are looking for those who want to make a difference

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.

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

• Support functions and projects in QA matters

• Providing QA training

• 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 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.

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.

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

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