Quality Assurance Lead
At MedBeat, we are building a solution to accurately monitor your heart everywhere and anytime. We are aiming to create a healthier society through meaningful work, innovation-focused, and customer-first health technology solutions. Help us improve the health and well-being of billions of people every year by joining our team as our Quality Assurance Lead!
Why should you join MedBeat?
A vibrant, young, and friendly work environment with diverse, highly skilled, and supportive colleagues with having fun and promoting a healthy work-life balance as core values
Be a part of developing a product that can make real change in healthcare
Innovative technology in a true R&D focused company with amazing tech stack
Generous wellness benefit
Part of a valuable startup community at Minc with a social and creative network in the midst of Malmö city center
Breakfast every Thursday, Afterworks, team and community events.
As our Quality Assurance Lead, you will be taking a leading role within QA/RA. You will be responsible for maintaining our ISO 13485 QMS and involved in quality assurance activities together with the product development team. You will ensure that MedBeat fulfils the regulatory requirements for quality assurance when medical devices are designed, developed, and distributed to the target markets. The role is quite hands-on and you will work with a broad range of tasks like product requirements, risk analysis, test and validation plans, our QMS, etc.
To succeed in this role, you’ll need a customer-first attitude and the following
3+ years of experience within ISO Quality Assurance
Experience working with MDR, ISO 13485 and IEC 60601 standards for Medical Devices
You are familiar with standards such as ISO 14971, IEC 62366, IEC 62304
You are highly skilled in reading and synthesising complex regulatory standards into understandable frameworks and policies for the organisation.
Preferred additional skills
Product development experience/background (Electronics, Mechanics, Software)
It is an advantage if you have prior experience of working within an RnD organisation, government authority, notified body or corresponding.
On a personal level
Strong communication and interpersonal skills
Good professional English language skills are required
You are structured and analytical and love to problem-solve
You are a clear communicator who can easily explain complex topics to anyone
You can work independently, drive your own projects and quickly get into new work-related situations
This job comes with several perks and benefits
Time is precious. Make it count. Morning person or night owl, this job is for you.
Get your caffeine fix to get you started and keep you going.
Easy access and treehugger friendly workplace.
Social gatherings and games; hang out with your colleagues.
Friday is something special, let's enjoy a beer together.
Peckish after lunch? We got your back with soft drinks, treats and fruit.