Quality Assurance Specialist with focus on Production support

About this opportunity

Quality is a promise to our customers, and medical device safety and quality compliance is a top priority at Getinge. As Quality Assurance Specialist in our Quality & Compliance team, you bring your experience from quality and compliance to improve our ways of working, leading to better product quality and higher customer satisfaction.

You join a the Quality Assurance team at Getinge Critical Care in Solna working in close collaboration with the quality team at our sister site in Germany. The team is responsible for the quality management system, supports manufacturing and supplier controls, performs final release of finished devices, hosts external audits, performs internal audits and leads CAPA activities. You report to the Senior Manager Quality and Compliance, Getinge Critical Care.

In this role, your primary responsibility will be to support manufacturing, including non-conformance handling and production process changes.

What you will do

You will help us improve product quality while maintaining compliance with the regulations. Your main tasks:

• Act as independent reviewer of production process changes, including process validation and production process risk assessments
• Support non-conformance handling in manufacturing and coordinate product holds for high-risk non-conforming products
• Support the organization on quality issues and improve procedures in the management system, specifically for manufacturing controls
• Support implementation, validation and management of software applications used in manufacturing and within the quality management system
• Perform internal audits and track non-conformances to closure, and support preparation of external audits and the CAPA (Corrective and Preventive Actions) process

This position is located in Solna but elibible for 1-2 days working from home.

You will bring

To be successful in this position, we believe that you have the following qualifications.

• Academic degree (M.Sc. or B.Sc.) in science or engineering
• 3-5 years of working experience from manufacturing of medical devices
• Documented knowledge of applicable regulations and standards, such as ISO 13485, MDSAP, QMSR and ISO 14001
• Strong verbal and written communication skills in Swedish and English
• Good track record of communication in cross-functional work, preferably in a global organization
• Experience in test method validation and computerized system validation is a merit

In addition to your technical skills, we highly value your personality. You are a result-oriented and cooperative team player who takes responsibility and can work independently, with an analytical and pragmatic mindset. You communicate efficiently and diplomatically with stakeholders at all levels and from different cultures, and you thrive in a changing environment.

We think you have an ambition for growth and an eagerness for keeping up to date with the latest in quality management and medical device regulation.

At Getinge we see ourselves as proactive and self-driven in learning and contributing to the continued development of our products and our organization's capabilities. We are Team Players, Forward Thinkers and Game Changers.

 

We think you will thrive in a high-expectation environment and have an interest in our products.

  

Why join Getinge

Getinge offers a job in a safe and informal work environment, where we appreciate close team collaboration. We keep an open dialogue between leaders and employees, as well as between teams. We are focused on developing people, and together we will create a plan for learning and competence development when you start your career with us.

We offer a competitive compensation and benefits package, including wellness allowances, generous family benefits and joint company activities. Everything to ensure we support your well-being and goals.

Application

Applications will be reviewed continually, and we therefore recommend sending us your application as soon as possible, but no later than 2026-12-10

We kindly ask you to submit your application in our recruitment system by clicking the “apply now” button. Due to GDPR regulations we do not accept applications via e-mail.

If you have any questions regarding the role, please contact Hiring Manager Katarina Blomberg, katarina.blomberg@getinge.com, or Talent Partner Emma Paulsson, emma.paulsson@getinge.com.

We look forward to receiving your application. We hope you will join us on our journey to become the world’s most desired MedTech company.