Sysmex Astrego – Together for a better healthcare journey

Do you want to work in a future-oriented industry where your efforts directly contribute to combating antimicrobial resistance on a global scale?

At Sysmex Astrego, we work toward something bigger than ourselves, improving how bacterial infections are diagnosed and treated and helping to slow the rise of antimicrobial resistance. We are a medical device company based in Uppsala, Sweden, and part of the global Sysmex Group. Here, scientific excellence, technology, and a genuine desire to make a difference come together.

Our product, the PA-100 AST System – winner of the prestigious Longitude Prize 2024 – enables rapid identification of both the bacteria causing an infection and its antibiotic resistance profile in under one hour.

We are a close-knit team of approximately 80 colleagues working together at our site in Ultuna, Uppsala. Our employee surveys consistently show high levels of engagement and strong sense of pride in what we do.

About the Role

We are looking for an experienced Senior Quality Assurance Specialist to become a key member of our Quality Assurance & Regulatory Affairs team in Uppsala. In this role, you will work cross-functionally across the organisation to ensure that our processes, products, and systems meet applicable regulatory requirements and industry standards. You will be part of a dedicated team of seven and report to the QA & RA Director.

This is a role for someone who enjoys combining structured quality work with hands-on problem solving and who wants to help shape quality culture in a fast-growing medical device company.

Key Responsibilities

• Implement and maintain the company’s eQMS (Greenlight Guru)

• Develop and maintain processes and documentation in accordance with ISO 13485:2016, ISO 14971:2019, and IVDR 2017/746

• Create, review, approve, and publish quality-regulated documentation

• Participate in and lead investigations of CAPAs, non-conformances, and customer complaints

• Lead and participate in risk management for products, processes, and equipment

• Lead and participate in qualification and internal verification/validation of products, processes, and equipment

• Plan and conduct internal and external audits

• Train staff and ensure awareness of current QMS requirements across the organisation

Your Profile

We are looking for someone who is thorough, solution-oriented, and comfortable working in a structured way within a dynamic environment. You have a natural ability to collaborate cross-functionally and communicate quality requirements clearly and accessibly – both internally and with external stakeholders.

Qualifications & Experience

• Master’s degree in a relevant field, such as biology, engineering, or quality management

• At least five years of experience in a similar role within the medical device or IVD sector

• Strong knowledge of and hands-on experience with ISO 13485:2016 and ISO 14971:2019

• Experience with Greenlight Guru is a plus

• Excellent verbal and written communication skills in both Swedish and English

Personal Attributes

• Comfortable working in a changing environment and handling unforeseen situations

• Detail oriented and well organised with a structured approach

• Proactive and solution focused with an analytical mindset

• Strong collaborative and communication skills with both internal and external stakeholders

What We Offer

Sysmex Astrego is committed to building an inclusive workplace that values diversity, where every employee has the opportunity to contribute their expertise and grow. Among other things, we offer:

• The opportunity to work with a world-unique product that makes a real difference to global health

• A place in an engaged, cross functional team with high competence and pride in their work

• A multicultural and inclusive working environment with a strong sense of community

• Competitive benefits and opportunities for professional development

We have a strong focus on being an on-site workplace, while also understanding the importance of flexibility in today’s working environment.

This position requires that you have the right to work in Sweden at the time of employment.

Interested?

We review applications on an ongoing basis. We warmly welcome your application as soon as possible!

* We kindly ask not to be contacted by external recruitment agencies or staffing companies. Thank you!