QA Specialist - Innovation Focus

Do you want to be part of a team where innovation and quality go hand in hand?

At Atos Medical in Hörby, we work together across functions like R&D, production, quality, and supply chain – all under one roof – to create life-changing solutions for people living with a neck stoma.

In this newly created role we are looking for someone who can represent QA in our development projects, making sure the projects are are compliant with standards and regulations.

About the Job

As a QA Specialist with a focus on innovation, you will play a key role in ensuring the quality and compliance of our new products as they move through the development process. You will be involved in multiple projects at different stages, acting as a critical link between R&D, production, and quality functions.

Your main responsibilities will include:

• Acting as the QA representative in development projects, ensuring compliance with medical device standards like ISO 13485.
• Reviewing and approving design history file (DHF) documents to make sure they meet quality and regulatory requirements.
• Providing guidance on quality management, risk assessments, and human factors engineering.
• Serving as the point of contact for quality-related aspects in innovation projects.
• Building strong connections with colleagues in production, quality control, and other cross-functional teams.

You will report to Head of QA at Atos Medical and have a dotted line to Director Quality Innovation Value Stream in our parent company Coloplast. The position is based in Hörby, with the opportunity to work from home up to 2 days per week. 

About You

You are a proactive problem solver who likes working with people across different teams. You are good at building connections, sharing knowledge, and breaking down complex information into clear, practical steps. We are an agile organization, and you have the ability to navigate in a dynamic environment, which can be a challenge, but also a lot of fun.

To succeed in this role, you likely have:

• A degree in biology, chemistry, biomedicine, or a related field (microbiology is a plus).
• 2–5 years of experience in a QA function
• Experience from a regulated industry.
• Solid understanding of quality systems and standards like ISO 13485.
• Experience working in cross-functional projects
• Experience with medical device production and/or design transfer to production is a benefit.
• Strong analytical skills and the ability to navigate complex technical challenges.
• Fluent English skills (Swedish is a plus)

Personal qualities that will help you thrive in this role:

• Building strong relationships and networks within the organization.
• Capability to navigate and coordinate demands from both local and global organization.
• Communicating effectively with colleagues at all levels.
• Continuously learning and applying new knowledge to improve processes.
• Adapting to changing priorities while staying focused on long-term goals.

Why Atos Medical?

At Atos, you will join a global leader in neck stoma care with a strong focus on innovation and patient outcomes. Our Hörby site offers a unique opportunity to work closely with colleagues from different functions, all collaborating to get our products to patients. We believe that when our people grow, our business thrives.

We also offer:

• A collective agreement, including reduced working hours.
• Flexibility with your time.
• Health perks through Epassi (lunch benefit + wellness grant).
• Breakfast at the office.
• A supportive, collaborative culture where you can truly make a difference.

Ready to take the next step?
Apply today and help us shape the future of medical innovation. We work with continuous selection, so do not hesitate to send in your application as soon as possible. Last day of application is June 15th.

For questions about the role, feel free to reach out to Malin Regebro at malin.regebro@atosmedical.com.

We aim to manage this recruitment without the support of external agencies, so we kindly refrain from being contacted in this matter.

Founded in 1986, Atos Medical is the global leader in laryngectomy care as well as a leading developer and manufacturer of tracheostomy products. We are passionate about making life easier for people living with a neck stoma, and we achieve this by providing personalized care and innovative solutions through our brands Provox®, Provox Life™ and Tracoe.

We know that great customer experience involves more than first-rate product development, which is why clinical research and education of both professionals and patients are integral parts of our business. 

Our roots are Swedish but today we are a global organization made up of about 1400 dedicated employees and our products are distributed to more than 90 countries. As we continue to grow, we remain committed to our purpose of improving the lives of people living with a neck stoma.

Since 2021, Atos Medical is the Voice and Respiratory Care division of Coloplast A/S

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