QA Manager

6 months ago

Malmö, Sweden Norrsken Foundation Full time

Elsa Science is growing and we can’t wait to meet you As our QA Manager, you will play an integral role in creating our story of supporting people living with a chronic disease.

Who we are and what we believe

Elsa Science is working toward a future where chronic disease is prevented. We do this by helping those living with a chronic condition to live their life to its full potential.

Our goal is to provide an educational and motivational digital platform that brings individuals, providers and the healthcare system together to manage chronic disease and empower the individual.

Our current focus is on delivering a service for rheumatic care management including a self care tool for patients, as well as a clinical decision support tool for healthcare providers. Together, our service enables patient self care and a proactive approach to provider’s treatment of the disease between visits, augmenting traditional patient care.

Who we are looking for

To be successful in this role we think that you are passionate about building quality foundations and working cross functionally with people, with a clear focus on making things happen and continuous improvement. 

You probably have

Broad experience from managing a Quality Management System A true quality mindset and excellent analytical and troubleshooting skills Strong interpersonal, writing and communication skills At least 5 years of experience from a Quality Assurance role, preferably in management position At least 3 years of experience from working with Medical Device Software (MDSW) or Software as a Medical Device (SaMD) Experience from risk management and software development lifecycle processes Understanding of international regulations and standards e.g. FDA QSR, MDR, ISO 13485, IEC 62304, IEC 62366 and ISO 14971 A calling to impact people's lives for the better

You need to be

Fluent in English Flexible and adaptive to a dynamic work environment A team-player who thrives in a growing team

On a day-to-day basis, you will

Plan, lead and execute on QMS procedures e.g. document and change control, training, audits, CAPA, NC, PMS, Vigilance etc. Drive continuous improvement activities
Collaborate with and support all functions in the organization
Participate in software development process and ensure design controls are followed
Lead a cross functional team in risk management activities
Ensure product documentation is generated and kept up to date


Our Values

We are caring

We care for each other, our partners and our users by showing compassion and respect, while constantly striving towards a healthier and more sustainable world.

We do this by:

Creating a safe, inclusive, welcoming and collaborative environment Taking care of our mental and physical well-being Taking responsibility and showing personal leadership Setting clear expectations and goals, and empower each other to reach them Building and implementing solutions that improve healthcare and empower the individual to live their best life

We are transformative

We explore, innovate, and challenge the status quo. We are not afraid to fail as we strive for positive change through learning, adapting, and iterating to create sustainable solutions that make a difference.

We do this by:

Exploring new ideas, concepts and opportunities with a curious mind Working in a sustainable and agile manner, while keeping a steady pace forward Constant iteration when designing, building and releasing compliant products and services that have an impact Sharing our failures, lessons learned, and successes

We are committed to science

We are committed to our cause, basing our work, research, and decisions on scientific evidence; assessing both quantitative and qualitative data through user testing and scientific papers before taking the next steps.

We do this by:

Starting with the whys and distinguishing between facts and hypotheses Using evidence-based ways of working, including scientific proof and references Carrying out our own scientific research and sharing it with the community Collaborating with patients, healthcare workers and other experts

What we offer

Employee stock ownership plan  Occupational pension The opportunity to dedicate two hours to physical activity on Monday mornings, we call it Hjärnstark or Brain Monday 36h work week (we have Friday afternoons free) 30 days of vacation year one and 35 days the second year and onwards A yearly wellness allowance (friskvårdsbidrag) of 3000 SEK Your mobile phone bill is covered up to 1 000 SEK per month, incl. cost of upgrading to a new phone A wonderful office in central Stockholm, with a possibility to work remotely

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