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Senior QA Specialist

You will be part of our QA Business Support Team, consisting of 12 QA Specialists and Senior QA Specialists, allocated to projects including innovation projects, capacity projects and strategic QA/QC projects. We participate in projects both as quality and compliance experts to ensure compliance with the requirements for Class III Medical Devices.

We are driven by improving patient outcomes and we take our values to work every day – we care about each other, our environment and our customers and we win for patients with innovative high-quality solutions.

Automationsingeniør med erfaring indenfor Pharma

Vil du arbejde med spændende og varierende projekter indenfor automation og kunne du tænke dig at blive del af et dygtigt tværfagligt team, hvor humøret og ambitionerne er tårnhøje?

Vi arbejder i Pharma automation teamet dedikeret med design, programudvikling, indkøring, test og kvalificering af procesløsninger til vores pharma og biotech kunder og du bliver således en del af vores tværfaglige projektteams.

På kontoret i Kalundborg vil du indgå i et professionelt fagmiljø, hvor der er fokus på vidensdeling og det gode samarbejde. Din dagligdag bliver præget af gode kollegaer, faglige udfordringer og stor medbestemmelse.

Test & Reliability Engineer - Sustaining Engineering, Medical Devices

Do you have a keen eye for Physical Testing, Product Quality, Reliability, Validation, and Documentation? Are you looking for an opportunity to merge your passion with our expertise in the Test and Verification of Infusion Care Medical Devices, for the treatment of chronic diseases such as Diabetes and Parkinson’s Disease?

As a Test Engineer, you will be involved in developing and working with a diversity of physical test methods. Planning and coordinating tests in our laboratory in Osted near Roskilde, and partners within Global Convatec and external. Most of your time, you will be part of a project team in SEG.

SAP Master Data Specialist

Do you want to be a part of Process Support in a company with a unique impact on global healthcare?

You will be coordinating SAP production master data activities throughout the organization in order to achieve safe and predictable product implementation, maintenance, and decommissioning.

Here you will not only get to impact the production and development of our products; you will also have every opportunity to develop and grow your own skills.

Biocompatibility Specialist

We are looking for a Biocompatibility Specialist to join the Reprocessing and Biocompatibility team for a 12-month project position.

This is a great opportunity if you would like to gain experience with biocompatibility for advanced reusable medical devices, as you will be part of a cross-functional effort on documenting the safety and performance through the lifetime of our ultrasound scanners, transducers, and accessories.

Training Partner

Are you passionate about designing high impact training to improve ways of working?

The role will focus on re-designing the training related to onboarding our professionals working directly with our operation, our Operators, and our Laboratory Technicians.

You will meet a DK rooted company growing in number of international colleagues and a way of working, where hybrid, digital, learning and innovation are key words.

Regulatory Affairs Specialist

The RA Specialist for Radiometer is responsible for ensuring coordination of regulatory activities for a few of our Blood Gas products manufactured in California to help ensure continued compliance in all markets.

In this role, you will have the opportunity to:

• Facilitate coordination of regulatory activities between California and Denmark for design control activities and international registrations for a few of the instruments/consumables manufactured in our California site.
• Ensure compliance with EU regulations.
• Generate STED files, international submissions & assess design changes.
• Plan and execute projects for new regulatory requirements.

Senior Regulatory Specialist

The Senior Regulatory Affairs Specialist at Radiometer is responsible for collecting and generating documentation for product submissions to ensure compliance with international regulations. This role is critical for ensuring that Radiometer's products can be sold in markets around the world.

If you thrive in a fast-paced environment, are used to playing a critical supporting role and want to work in a world-class efficient team that is part of a Global RA department and have interactions and stakeholders to connect with in a global scale - read on.

Regulatory Affairs Manager

The Regulatory Affairs Manager at Radiometer is responsible for managing the preparation and submission of the required documentation for product registration, approval, and compliance with international regulations.

This role is critical for ensuring that Radiometer's products can be sold in markets around the world. You will have the opportunity to:

• Ensure regulatory compliance to maintain market approvals
• Lead a team of skilled RA associates
• Ensure alignment with relevant stakeholders

Senior Engineer Device Manufacturing

Are you passionate about cutting-edge medical technology? Do you thrive in a collaborative environment where innovation drives patient care?

Amgen, a global biotechnology leader, is expanding its device development capabilities in Denmark and is seeking a talented Senior Engineer to join our Device Engineering group.

Laborant eller procesoperatør til bufferproduktion til cancerdiagnostik

Vil du bidrage til diagnostik af cancer og gøre en forskel for patienter? Bliver du motiveret af laboratoriearbejde i et travlt produktionsmiljø? Er du detaljeorienteret og lægger vægt på korrekt produktion og dokumentation?

Vores hverdag består hovedsagelig af produktioner, grundig dokumentation og reviews men vi prioriterer også tid til løbende forbedringer af vores arbejdsgange og processer.

Der er tale om en fuldtidsstilling på 37 timer per uge. Arbejdstiden ligger i dagtimerne og vi har flextid.

Senior Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

You will become a process owner of one or more of our production processes in SFI. This means that you will be responsible for, among other things, validation documentation, revalidations, and risk assessments for the specific process.

QA Tekniker

Vil du være en del af QA Operations Support i en virksomhed med en unik indvirkning på det globale sundhedsvæsen?

Grib denne mulighed for at blive en del af vores hurtigt voksende virksomhed, som er klar til at investere i dig. Hos os vil du ikke blot få muligheden for at påvirke produktionen af vores produkter – du får også mulighed for at udvikle dig i vores QA Operations Support Team, hvor vi ekspanderer for at kunne følge med og fortsat at kunne levere den ønskede høje kvalitet.

Process Specialist

Do you want to be part of Process Support in a company with a unique impact on global healthcare? Grab this opportunity to be part of a fast-growing company ready to invest in you.

Together with the rest of the team, you will be responsible for the daily support of our production lines. You will learn our processes in detail and gain a good overview of the documentation used in production.

Technical Writer to GE HealthCare Denmark

Join GE HealthCare to help develop high quality instructions for use for our ultrasound scanners, transducers, and reprocessing methods in compliance with rules and legislation in various countries. This is your opportunity to become part of an innovative team where your work has a real impact on people’s lives around the world.

Our Technical Documentation team consists of six dedicated and passionate specialists with a mix of seniority, educational backgrounds, and nationalities. Our Technical Writers develop and maintain the user documentation for our high-performance equipment.

QA Specialist

You will be responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms.

You will have the opportunity to:

• Provide Design Control guidance for QMS and regulatory compliance in an FDA regulated and ISO compliant environment.
• Represent Quality Assurance in design and development projects and in cross-functional teams supporting new product development.