As part of Neko Health’s continued expansion, we are looking to recruit an experienced Quality Assurance Manager. The successful candidate will form part of a growing compliance team in an innovative startup that is reimagining preventative healthcare by innovating in scanning technology.
About the Role
In this role you will work with a skilled and highly engaged cross functional team of engineers and technologists and be responsible for reviewing and implementing Quality Management Systems (QMS) and must be passionate about enabling the delivery of preventative healthcare services.
Your key responsibilities will include:
· Primary process owner in QMS and the QA representative
· Developing and implementing QMS to comply with applicable standards, regulations and guidelines including process strategy. This also includes contributing in process development related to testing, clinical investigations and cyber security
· Take an active role in the certification of our QMS (Notified Body and MDSAP, etc.)
· Responsible for internal/external audits such as personnel, management, production, etc.
· Daily and strategic maintenance and improvements of QA processes. This includes performing management review and measurement of QMS effectiveness
· CAPA activities, handling of complaints, recalls and incidents
· Production release, acceptance tests. Quality control (QC) in production
· Handling of subcontractors and quality agreements
· Training of (new) staff within QA/RA
· Risk analysis of company-related risks linked to Compliance
· Leading specific projects in relation to medical device processes and documentation as requested by the board.
Location: Stockholm, Sweden
Candidates should have a technical Bachelor/Master of Science or university degree in a relevant product or medical area, for instance:
· Computer and Software Technology
· Electronic, Electrical and Medical Technology
· Biomedical Engineering
Candidates must have a minimum 5 years’ work experience in a medical device related industry, of which at least 3 of these years in QMS (preferably ISO 13485). A PhD and research background with relevant experience will be a bonus.
Work experience should include interacting with regulatory authorities, applying risk management principles and methodologies, and developing and implementing effective quality management systems.
To be considered for this role, you’ll have professional experience in healthcare products and services, for example:
· Working in the medical devices industry in a quality management capacity
· Working in the application of device technology in health care services
· Software programming experience would be highly beneficial
· Conducting evaluation studies, performance testing or clinical studies of devices
In addition to the above you’ll also need to demonstrate the following:
· Work experience in positions with significant QA, Regulatory or management systems responsibility
· Experience with Risk Management ISO 14971, ISO 13485, IEC/EN 60601, MDR 2017/745. Documented experience in IEC 62304 is beneficial.
· Being a self-starter prioritizing workloads in a rapidly growing organization
· Fluency in Swedish and English and excellent communication and influencing skills.
· A love for learning and a flair for technical writing and fun.
If you're interested in applying, please submit your CV and cover letter in English or Swedish. You must live inside the EU to be considered for this role.
Interviews will be held on an on-going basis.
Company & Business Area Description
Neko Health is a Swedish health-tech company co-founded in 2018 by Hjalmar Nilsonne and Daniel Ek. Our vision is to create a healthcare system that can help people stay healthy through preventive measures and early detection. Neko has developed a new medical scanning technology concept to make it possible to do broad and non-invasive health data collection that is both convenient and affordable for the public. This requires completely reimagining the healthcare experience and incorporating the latest advances in sensors and AI. We are a remote first company, but the company is based in Stockholm and has 40 employees across Europe.
Equal Opportunity Statement
Neko Health is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to race, national or ethnic origin, gender, cultural background, social group, religion, disability, sexual orientation, marital status, age or political opinion. Diversity is important to us and a competitive advantage!