Blueprint Genetics, a Quest Diagnostics company, is a clinical genetic testing company aspiring to bring genetic knowledge to mainstream healthcare. We want to improve the lives of individuals and families impacted by inherited diseases. Our global team is growing, and we are now looking for a Senior Software & Compliance Specialist to join us.

Job Description

As a Senior Software & Compliance Specialist, you will maximise the value of our proprietary software solutions for external and internal customers in an agile way. You will work closely with our teams across the whole organisation. We aspire to grow our capabilities by hiring people who understand agile principles of modern software processes.

Your work consists of developing and maintaining medical device quality assurance processes to meet relevant regulations in software development. You will collaborate with software team and quality team to fulfil regulatory and compliance requirements of software products, services, and processes (IVDR, GCLP etc). With quality team, you will coordinate the audits and corresponding reviews for software processes and offer support for computerized systems validation. You must be able to interpret audits data, identify areas of concern and develop a corrective action plan.

What we expect from you

Experience in the health care industry and with its regulations such as MDR and IVDR
Experience with creating and following compliant software development life cycle processes following standards and guidelines such as IEC 62304/82304, AAMI TIR45 and GxP/GAMP5
Team spirit - it's in our DNA: mutual respect, open communication, togetherness, problem solving and innovation
Good organizational and decision-making skills
Problem solving abilities combined with good documentation and reporting competence
Excellent communication skills (we speak English at work) with the ability to engage, influence and inspire others to drive collaboration and alignment
Proactive mindset and self-starter attitude

What differentiates you

Experience with both Software as Medical Device and Computerized System Validation
Experience with clinical laboratory quality management systems and processes
Experience in quality management systems for IVD Medical Devices including ISO 13485 compliance
AWS technical stack knowledge
Hands-on software development background

What we offer

The opportunity to work for a 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 positive, open, and international work environment with great people from different fields of expertise. We are a team of close to 250 experienced professionals, who collaborate to drive genetic knowledge forward.
Employee benefits such as participation to performance-based bonus payment system, extensive occupational healthcare with Heltti, lunch benefit, sports, culture & wellbeing benefit, mental wellbeing with Auntie, on-site gym membership, team events & office parties.

How to apply

Does this sound like your next career move? All you need to do is submit your CV or link to your LinkedIn profile at the latest on 17th of December. We will start interviewing already during the application period, so we hope to hear from you soon!

If you have any further questions about the position, you can contact Ville Kytölä on ville.kytola(a)blueprintgenetics.com.

Our hiring process includes:

An interview with the hiring managers
An interview with a couple of team members
Reference checks

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

Blueprint Genetics Oy

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