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Quality Assurance Lead - ISO13485

Salary Competitive

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.


The role

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

For more information or questions please contact us at sebastian.wicksell@medbeat.se

Perks and benefits

This job comes with several perks and benefits

Flexible working hours
Flexible working hours

Time is precious. Make it count. Morning person or night owl, this job is for you.

Free coffee / tea
Free coffee / tea

Get your caffeine fix to get you started and keep you going.

Near public transit
Near public transit

Easy access and treehugger friendly workplace.

Social gatherings
Social gatherings

Social gatherings and games; hang out with your colleagues.

Free friday beers
Free friday beers

Friday is something special, let's enjoy a beer together.

Free office snacks
Free office snacks

Peckish after lunch? We got your back with soft drinks, treats and fruit.

See all 13 benefits

Working at
MedBeat

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!

Read more about MedBeat

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