15 job matcher din søgning
Unomedical A/S, Osted
For our business unit ConvaTec B2B “Unomedical” at Osted, near Roskilde, we are looking for a committed Category Manager with the responsibility for Injection Molding and Resin Sourcing activities.
The successful candidate will be part of the Direct Sourcing Team of currently 7 competent employees working in close cooperation with other departments in the company especially Logistics, R & D, Sales & Marketing, QA/RA, and with our production sites in Denmark and Mexico. Yearly travel activity of approximately 40 days are to be expected.
- Drive price and contract negotiations with a strong focus on supplier relationship and cost optimization
- Identify potential suppliers for new and existing products and follow up on existing suppliers
- Participate in projects on new and existing materials ensuring a smooth running of current production at our suppliers
Hartmanns A/S søger for Unomedical B2B, a ConvaTec company i Osted
Som Product Quality Engineer vil du som ”one point of contact” være kvalitetsafdelingens repræsentant i virksomhedens forskellige projekter og være ansvarlig for, at al projektdokumentation er i compliance med såvel interne som eksterne krav, for at sikre indhentning af FDA-godkendelser og vedligehold af CE-mærkningen. Du bliver del af et team på 7 Product Quality Engineers med reference til Associate Director for Product Quality Engineering.
Varierede opgaver med udfordringer og selvstændigt ansvar
- Projektdeltagelse med hovedansvar for at interne og lov- og myndighedskrav overholdes (kan være både ift. R&D, Change- eller Capacity-Teamet efter din profil og ønsker)
- Opdatering og udvikling af DMR-dokumentation i forbindelse med projekter
- Ansvar for Risk Management i projekterne samt review og godkendelse af test- og designverifikationsdokumenter
Team Consult søger for IVFtech ApS i Stenløse
IVFtech ApS har 22 ansatte og søger, som led i fortsat ekspansion en elektroniktekniker til udviklingsafdelingen til en alsidig stilling. Du får mulighed for at påvirke udviklingen af medicinske produkter til fertilitetsbehandling, der er et område i kraftig vækst.
Vi arbejder løbende med forskellige projekter, og er i øjeblikket ved at produktionsmodne et avanceret produkt der indeholder elektronik, mekanik og gasblandingsreguleringsteknik.
Du indgår i et lille team af fastansatte og konsulenter, og vil være bindeleddet mellem udviklingsafdelingen og produktionen. Hovedopgaverne vil være test af prototyper, og klargøring af disse til produktion. Dine opgaver bliver at sikre at produktet kommer i mål, i den godkendte høje håndværksmæssige kvalitet. I travle perioder giver alle en hånd med i selve produktionen, indenfor det område man dækker bedst.
Unique Human Capital recruiting on behalf of Ascendis Pharma A/S in Hellerup
In a fast growing biotech company
As QMS Manager at Ascendis Pharma, the main success criteria is to create a good understanding of QMS guidelines and procedures in order to support the different business areas. Ascendis Pharma has just launched a new cloud-based Electronic Document Management System (EDMS) and in cooperation with all functions across Ascendis Pharma worldwide, you will contribute with your knowledge within QMS to ensure compliance according to requirements. You will be part of a global QA team and become part of a very exciting journey taking Ascendis to the next level.
Your main responsibilites are:
- Drive the implementation of the QMS module of the EDMS
- Apply your experience and knowledge with Standard Operating Procedures in the establisment and implementation of Ascendis Pharma’s Quality System
- Design and implement global training processes
Y-mAbs Therapeutics A/S, RungstedA new position is now open! Y-mAbs Therapeutics A/S (YmAbs) is looking for a CMC Project Manager. You will primarily focus on CMC activities associated with our late stage development programs, and you work with CMC interfaces to other functional groups within YmAbs. A good understanding of the outsourcing process, from quotations and contract negotiations to follow-up and troubleshooting with our CMC partners is a key competence as all manufacturing is outsourced.
- You will manage, coordinate and drive the Chemistry, Manufacturing and Control (CMC) part of projects in early and late stage development with specific focus on analytical and stability issues
- Coordinate development activities within drug product formulation, assay development, control strategies, and quality control using external vendors (CRO’s)
We are looking for a Senior Software Project Leader that can head up our activities for a large part of the software and embedded solutions roadmap. We are more than 500 Engineers in our Research & Development department, designing and developing one of the world’s best hearing aids from chipsets to Software, Firmware, Hardware and App’s.
You will be responsible for the total Software platform development for our Hearing aid products and bring new Software solutions from product roadmap level into implementation and verification in released products. An important aspect of the job is to help us transition our development flow into an even more agile approach. We are therefore looking for practical and ‘hands on’ experience within agile development practices, methodologies and tools – i.e. clarifying user stories, refining our product backlog, collaborating with scrum masters, Product Managers etc.
Y-mAbs Therapeutics A/S, Rungsted
Come join our experienced and dedicated team! Y-mAbs Therapeutics A/S (YmAbs) is now looking for a Regulatory Submission Manager.
As Regulatory Submission Manager your function will be to prepare for BLAs/MAAs submissions, CTA submissions and oversight, and to coordinate Question/Answer rounds between the health authorities and YmAbs. You will also provide regulatory intelligence and input to regulatory strategies for our projects with the overall goal of developing new and innovative treatment for both pediatric and adult cancer patients.
- Coordinate and prepare regulatory submissions
- Tracking health authority correspondence together with our CROs
- Ensure timely follow-up on health authority commitments/requirements
Radiometer Medical ApS, Brønshøj
This job is the perfect opportunity to combine passion for technology such as software, hardware, electronics, mechanics and chemistry with the ability to track quality aspects related to:
- Risk Management
- Requirement management
- System engineering and architecture
- Validation and Verification
- Design planning
You and the QA Engineering team plays a significant role in ensuring safe, reliable and compliant products during new product development and maintenance of existing products. You do this by cooperating, supporting, facilitating, training and communicating with partners in R&D.
Pharmacosmos A/S, Holbæk
Pharmacosmos søger nye dygtige medarbejdere, der kan arbejde i vores produktionsafdeling.
Produktionen er delt op i to produktionsafdelinger hhv. produktion af Dextran/Dextran derivat og produktion af jerncarbohydrate. Vi arbejder i mindre teams, alle med direkte reference til en teamleder.
I produktionsafdelingen arbejder vi på skiftehold. Vi har et fast nathold samt faste hold der arbejder i dag/aften skift på ugeplan. Vi søger medarbejdere til dag/aften skift.
Du kan se frem til en hverdag med mange og varierede arbejdsopgaver, men hovedvægten i jobbet ligger på udførelse af selve de enkelte enhedsoperationer i forbindelse med produktion af vores produkter.
Copenhagen Search Partners P/S recruiting on behalf of client
Are you a strong leader? Do you have a solid technical background and experience in developing a team of Engineers/Technicians? Are you multi-lingual? And would you like to be a part of an international company in rapid growth? Then you may be the one we are looking for!
As the new Senior Service & Repair Manager, you will build, manage and develop a high caliber technical team that perform the field service activities in the company. It will be your responsibility to supervise and coordinate all field service, maintenance and repair activities within Europe and provide support for APAC by leading and directing the work of Fields Service Engineers. You will perform or shadow Field Service and Repair duties periodically.
Genmab A/S, København
As Senior Medical Writer you will be responsible for driving, developing and writing clinical documents to support operational, medical and regulatory activities across Genmab projects.
Your key responsibilities will be:
- Draft and edit documents used during clinical trial conduct and reporting including clinical trial protocol, investigators brochures and clinical study reports
- Drive trial team participation in the preparation of such documents, including calling/scheduling/running meetings, developing and managing timelines, document review and decisions
- Support developing and reviewing standard processes and templates
Thermo Fisher Scientific, Roskilde
Do you want to be a part of a company known to be a fast paced global leader in serving science? Are you passionate about making a difference, and are you looking for a role where you can assume the responsibility for directing and developing Regulatory Affairs, whilst applying your RA expertise within Medical Devices, then you may be the one we are looking for.
Reporting to the Quality Senior Manager this newly created and key role will provide RA guidance in projects (e.g. development), maintain and update medical device regulatory filing (MDR, IVDR) including product registrations, FDA 510k`s, and Technical Files.
- Prepare, submit and manage regulatory filings required for product market approvals and registrations in different markets as necessary
- Prepare, submit, manage and maintain Technical Files in compliance with the requirements of the MDD/IVDD and the Quality Management System