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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 Product Test Engineer - Medical Devices

Do you want to design safe and reliable medical devices, bringing our clients' life-changing solutions into the hands of patients and helping patients to get better treatment?

You will be an essential contributor in the development and designing optimal verification methods for requirement confirmation.

We seek to enable the best work environment that helps you and the business work together to produce superior results.

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.

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.

Category Manager

Do you want to be responsible for developing our Sourcing of Packaging and Raw materials to new heights? Do you want to make a difference for patients undergoing surgery by securing the compliance of the medical devices used by healthcare professionals?

We offer an inclusive workplace with the opportunity to have real impact and a development curve, that you can steepen in the pace, that is suitable to you. 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. And we take pride in having fun.

Senior Category Manager

Here you have the opportunity to get an exciting and challenging job, as Senior Category Manager, in a international company. As Ferrosan Medical Devices is growing, you will be able to shape the job in our Strategic Sourcing Department to a large extent. The position refers to the Senior Manager of Strategic Sourcing.

We offer a truly purpose driven workplace with strong roots in values. What exactly this means is quickly visible to our new colleagues. 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.  

Continuous Improvement Leader

You will cover a fundamental position within the EMEA Continuous Improvement team for Kimberly-Clark Professional. You will be responsible to provide leadership, vision, coordination and functional direction to the Mill leadership team for all elements to the development, introduction and sustainability of LEAN operating principles.

: we can offer a hybrid model (on remote 2 days/Koblenz Mill 3 days per week) for candidates already based in Koblenz Area.

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.

Senior QA Specialist

The Senior QA Specialist for Radiometer is responsible for ensuring safe, reliable, and compliant products during new product development and maintenance of existing product platforms. This is done by cooperating, supporting, facilitating, training, and communicating towards the best results with partners in R&D.

This position is part of the QA Design Control department, hybrid based and located in Brønshøj. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

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.

Assisting Product Manager

Til vores Product Management Team har vi brug for en vedholdende og insisterende personlighed, der formår at stille spørgsmål og arbejde aktivt med problemstillinger, som ikke nødvendigvis har en løsning lige for.

Stillingen er fast, og dine ansvarsområder vil primært være indenfor validering af problemløsninger samt at vedligeholde og opdatere den eksisterende dokumentation til sikring af høj kvalitet på vores produktlinjer. Med tiden vil du fungere som projektleder for udgivelse af opdateringer til vores eksisterende produkter.

Laborant til Incoming QC

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

I Incoming Quality Control (IQC) foretager vi kvalitetskontrol af råvarer og Outsourced supplier materials, hvor vi sikrer at den korrekte dokumentation er tilstede, før vi godkender råvarerne til produktion. Desuden foretager vi test af nogle råvarer, ELISA tests, Bioburden og analyser af vandprøver.

Hverdagen består hovedsageligt af grundig kvalitetskontrol af dokumentation og reviews samt laboratoriearbejde, men vi prioriterer også tid til løbende forbedringer af vores arbejdsgange og processer.

QA Specialist med et stærkt kvalitetsmindset søges

Motiveres du af at være med til at sætte retningen i en helt ny virksomhed?

Som QA Specialist bliver du en nøgleperson i forhold til rådgivning og supportering i produktionen så det sikres, at produkter under udvikling lever op til både interne og eksterne standarder.

Du vil få udfordringer og opgaver, der vil give muligheder for at udvikle dig både fagligt og personligt.

QA Tekniker / QA Release

Vi søger en kompetent og initiativrig QA Tekniker, der vil være med til at bidrage til den fortsatte udvikling af Elos Medtech QA-område.

Målrettet træning/uddannelse vil blive gennemført, så lad dig ikke begrænse af, at den ideelle kandidat vil passe til en eller flere af nedenstående forventninger:

• Omhyggelig, struktureret og har øje for helheden samt kommunikerer konstruktivt og sætter en ære i at sikre, at vores produkter efterlever de høje kvalitetskrav
• Erfaring med Axapta eller andet ERP-system
• Kendskab til GMP-regler, ISO 13485 og/eller ISO 9000
• IT-kyndig og rutineret bruger af MS Office pakken