Software Quality Manager

Cepheid is a leading molecular diagnostics company dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In Solna, we develop and manufacture diagnostics tests that improve patient outcome all over the world.
We are still growing and are now in search of our next leading star who is passionate about quality to join our Software Quality team!
The role
The Software Quality Manager’s primary responsibility is to supervise and lead the local Software Quality team, consisting of QA representatives in projects and SCRUM teams. It includes functional responsibility of software validation, risk management, and quality assurance of software development projects.
The overall aim is to build quality into the software from the start and you will get an outstanding opportunity to teamwork cross-functionally with project managers, product owners, technical leads, verification leads etc from various departments of the organization, assuring alignment with established procedures and foster a quality focused mindset in the project and SCRUM teams.
Responsibilities


Build and develop a robust team of Software Quality Specialists through recruiting, coaching, engagement-, and performance management
Connect with cross-functional teams including Software Engineering, Program Management, Product Owner, Regulatory Affairs, Global Product Support etc, for efficient collaboration and reduce product time to market
Develop, implement, and continuously improve Quality Systems processes to support software product development
Represent Software Quality in software project teams
Ensure all software validation activities in development projects are carried out sufficiently and in a timely manner in terms of planning, execution, reporting and documentation
Ensure cybersecurity and safety risk management activities are planned and carried out based on product type and classification
Assure that established procedures in the Quality Management System are aligned with applicable global regulatory requirements
Support internal and external audits as Subject Matter Expert for Design Controls for software projects

Qualifications
We believe that to succeed in this position you have a Bachelor's degree, preferably an advanced degree within Computer Science or similar. This combined with following experience will increase your chances of being qualified for joining our team:


Demonstrated ability in Software Quality Assurance (minimum 8 years) and at least 3 years of proven experience in people management and leadership
Training and certification in Medical Device Software, Software Validation, Lean Software Development etc, is advantageous
Experience from working with cloud system validation and qualification in relation to Part 11 and/or Annex 11 in medical device industry is advantageous
Experience from leading cybersecurity and safety risk management activities in medical device or diagnostic industry is advantageous
Demonstrated knowledge of domestic and international quality systems and standards such as FDA QSR, MDD, ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 27001, and other applicable standards and regulations
Demonstrated knowledge about General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPAA) and its application to Cloud software and Medical Device Data Systems

We believe that as a person you have strong interpersonal skills and can connect with all kinds of people throughout an organization. You are by nature analytical, self-motivated, and eager to learn new concepts and technologies. You are most likely also dedicated to quality and want to work hard for the happiness of our customers around the world.
What we offer
We offer you to be a part of a fast-paced and fast-growing, but yet friendly and diverse company, where you will find it meaningful to go to work. We take ownership in caring for our employees, and also offer a wide range of benefits, which include a competitive salary, additional days of leave, a fitness grant, a local gym, etc. Together we work hard to make a difference.
We are interviewing continuously, so make sure to submit your CV today so that we can get to know you!