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Project Manager

Trives du med at arbejde sammen med dedikerede og erfarne kollegaer, der brænder for at udvikle og producere medicinske hjælpemidler til børn og unge med funktionsnedsættelse?

Kan du samtidig se dig selv som projektleder i en specialiseret verden, hvor innovativt design, teknik og brugervenlighed skal gå op i en højere enhed, så er det dig, vi søger i vores R&D-afdeling i Gedved ved Horsens.

Product Compliance Specialist

Ønsker du at arbejde sammen med dedikerede og erfarne kollegaer, der brænder for at udvikle og producere hjælpemidler til børn og unge med funktionsnedsættelse?

Du vil medvirke til at sikre, at de regulatoriske krav til medicinsk udstyr (klasse I) bliver overholdt.

Vi ønsker bl.a. følgende opgaver dækket med vores nye kollega:

• Ansvarlig for godkendelse af nye produkter sammen med R&D teamet
• Deltage i nyudvikling herunder udarbejdelse og godkendelse af regulatorisk dokumentation

Som ansat hos R82 er der stor fokus på både personlig og faglig udvikling af den enkelte medarbejder.

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.

Continuous Improvement Partner

As a Continuous Improvement Partner in Drug Substance Manufacturing, you will be part of a team of Improvement Partners who develops and sustains systems and tools that enables the organization to consistently increase the level of operational excellence in manufacturing.

Your primary tasks will include but not be limited to:

• Develop and sustain CI systems and tools.
• Coach on ideal behaviour that drives a proactive improvement culture.

External Lecturer – “Public Health Emergencies and Health-Crisis Management” – DIS Stockholm

DIS Stockholm is currently hiring one external faculty to co-teach the elective course Public Health Emergencies and Health-Crisis Management to highly motivated undergraduate students from North American universities who are spending a semester studying in Stockholm.

Work in an international, informal and enthusiastic environment with an emphasis on cross-cultural understanding, teamwork, innovation, and adaptability.

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

Coordinator in Quality

Are you our new coordinator within Quality? Do you enjoy working with Planning & Forecasting, Contract Laboratory Organization (CLO) management, Reference standard & Control management - then join our Data Management team within Quality in our site in Hillerød.

You will be the point of contact for CLO´s used within Quality Control (QC) ensuring the relationship and making sure contracts are in place. Your responsibilities will include monitoring of inventory levels, providing status to management and facilitating the timely delivery of products to customers.

Raw Material Sampler for QC Raw Materials Sample Team

You will be working in the QC Sample team, a small team that of now consist of four employees and a manager, but the team is still growing.

Your primary tasks will be but not limited to:

• Sampling and inspecting raw materials in classified areas according to specifications
• Logging samples in LIMS and documenting compliance in SAP
• Expiry setting and checking quality information from our vendors on materials received

We offer an exciting journey on a fast-growing commercial pharma site with lots of development opportunities.

Sr. Project Lead, DSM expansions Go-Live

Are you seeking a new and exciting challenge in the Biopharmaceutical Industry?

Your primary tasks will entail but not be limited to driving the successful execution of project deliverables, facilitating workshops, and drive the realization of project track.

Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.