Quality Management System Lead
21 hours ago
About Radiobotics ApS
We are a dynamic and innovative company dedicated to solving the global need for radiologists while ensuring every patient receives expert-level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and first-line reported by our products.
We are seeking a Quality Management System Lead to join our team. As a key member of our Clinical and Regulatory team, you will be responsible for defining and delivering our strategy to maintain superior product quality and regulatory compliance.
The successful candidate will have a strong background in quality assurance and/or regulatory affairs, with experience in quality management systems and regulatory requirements within MDR and ISO 13485. You will be expected to review and revise QMS procedures, assist management in prioritizing regulatory approval activities, and participate in audits.
Your main responsibilities will include:
- Leading product release projects in collaboration with the project manager from the development team
- Supporting other departments in design control
- Taking lead on the risk analysis for new products, with support from our clinical and development team
- Reviewing and revising QMS procedures to ensure they are efficient and effective
- Assisting management in prioritizing regulatory approval activities based on strategy and market potentials
- Creating and coordinating the product submissions for the devices we develop (possibly supported by consultants)
- Training the company in QMS procedures
- Participating in audits, both internal and external
To succeed in this role, you will need excellent communication skills in English and experience with working within or leading cross-functional projects. Knowledge of software as a medical device and a positive can-do attitude with a thorough and structured mindset are also essential.
We offer a competitive salary and a range of benefits, including flexible working hours, free coffee/tea, social gatherings, free office snacks, and free Friday beers.
At Radiobotics ApS, we believe in transparency, integrity, and pursuing big ideas. We strive to learn what happens beyond the surface and show up every day ready to engage and have fun with each other.
-
Quality Management System Developer
1 day ago
Copenhagen, Copenhagen, Denmark TRS Staffing Solutions Full timeWe are seeking an experienced Quality Manager to lead our quality control and assurance efforts on a large project in Denmark.The ideal candidate will have a strong background in quality management, excellent communication skills, and experience working with cross-functional teams.This role involves overseeing quality management processes, coordinating with...
-
Quality Management System Professional
17 hours ago
Copenhagen, Copenhagen, Denmark The HubDanske Bank Full timeIn this role, you will have the opportunity to work on a wide range of projects, from developing and implementing quality management systems to collaborating with cross-functional teams to deliver high-quality products. As a QA/RA specialist, you will be responsible for ensuring compliance with regulatory requirements, including MDR and ISO 13485.Our TeamYou...
-
Compliance Specialist
21 hours ago
Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full timeAre you a motivated and detail-oriented professional looking for a new challenge? Do you have a passion for quality management and regulatory compliance? Look no further than Radiometer Danmark!We're seeking a QA/QMS Professional with Danish language skills to join our team as a Compliance Specialist - Quality Management Systems. In this role, you'll be...
-
Expert in Quality Assurance Systems
4 days ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timePARETO SECURITIES AS is seeking a highly motivated and experienced Expert in Quality Assurance Systems to join our Quality team. In this role, you will be responsible for developing and implementing our Quality Management System (QMS) to ensure compliance with industry standards.About the CompanyPARETO SECURITIES AS is a dynamic and innovative company that...
-
Quality Management System Expert
21 hours ago
Copenhagen, Copenhagen, Denmark Lundbeck AS, H Full timeOur VisionLundbeck A/S is committed to transforming lives by addressing the big unmet needs of people living with brain disorders.We believe in fostering an inclusive culture where every voice matters, and we are dedicated to building a diverse workforce that reflects the patients we serve.Job DescriptionAs a Business Partner, you will play a key role in...
-
Quality Assurance Manager
5 days ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timeCompany OverviewPareto Securities AS is a leading engineering services company with a proven track record of high-quality, customer-focused project delivery. Our core divisions include Mechanical Engineering, Electrical Engineering, and Fire Protection.We offer competitive salaries, financial support for further training, Continuous Professional Development...
-
Quality Management System Expert
13 hours ago
Copenhagen, Copenhagen, Denmark Eupry Full timeAbout the Role: We are seeking a highly skilled QA / QC Specialist to join our team. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and process improvement.Key Responsibilities:Develop and implement strategies to improve QMS processes and proceduresCollaborate with cross-functional teams to resolve...
-
Project Lead Quality
2 days ago
Copenhagen, Copenhagen, Denmark TRS Staffing Solutions Full timeGet AI-powered advice on this job and more exclusive features. Helping companies achieve success by placing world-class Engineering Talent within the Renewables and Oil & Gas sectors Our client is proud to design and build projects and careers. This requires teams that are as unique as the projects we execute. We are committed to fostering a work environment...
-
System Integration Lead
19 hours ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timePareto Securities A/S: Job DescriptionJob Title: System Test ManagerThis role involves overseeing the system test of our state-of-the-art radars. As the technical lead for a team of System Test Engineers, you will be responsible for defining and executing our system test strategy for our products. You will work closely with development teams to design and...
-
Quality Management Specialist
2 days ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timeDo you have expertise in implementing structured processes and maintaining quality management systems (QMS)? Are you looking for a role where you can establish quality actions and focus continuous improvement in an expanding organisation? Then this job is for you. At Weibel, you will join an international, technology-driven company that delivers high-quality...
-
Quality Assurance Lead
2 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAt Genmab, we're driven to transform the lives of patients through innovative cancer treatments. Our team is passionate about pioneering therapies that make a meaningful difference in the world.We're seeking a highly motivated QA Senior Manager to join our global quality assurance team. As a seasoned expert in GCP and GCLP regulations, you'll play a key role...
-
Scanning System Quality Assurance Professional
13 hours ago
Copenhagen, Copenhagen, Denmark 3Shape Full timeAbout the JobAs a Scanning System Quality Assurance Professional, you will play a crucial role in ensuring the quality of our dental systems, which combine hardware and software components. You will work closely with cross-functional teams to improve the quality aspect of our development projects.Your responsibilities will include leading quality assurance...
-
Dental Systems Quality Assurance Specialist
21 hours ago
Copenhagen, Copenhagen, Denmark 3Shape Full timeAbout the roleWe are seeking a skilled Quality Assurance Specialist to contribute to developing dental systems, combining hardware and software components. This specialist will work on improving the quality aspect in our development projects as part of a cross-functional team.You will collaborate with colleagues from R&D, product development, scientific...
-
Quality Management Professional
4 days ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timeWe are seeking an experienced Quality Management Professional to join our growing Quality team at PARETO SECURITIES AS. In this role, you will be responsible for driving the development of our Quality Management System (QMS) to ensure compliance with industry standards such as ISO 9001 and AQAP.About the RoleThis is a key position that requires a strong...
-
Compliance and Quality Manager
4 days ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timeWe are seeking a highly experienced Compliance and Quality Manager to join our Quality team at PARETO SECURITIES AS. In this role, you will be responsible for ensuring that our Quality Management System (QMS) complies with industry standards such as ISO 9001 and AQAP.About the RoleThis is a key position that requires a strong understanding of quality...
-
Training Manager, IT Quality Lead
19 hours ago
Copenhagen, Copenhagen, Denmark H. Lundbeck AS Full timeAt H. Lundbeck A/S, we are seeking a visionary Training Manager to join our team. As a Training Manager, you will play a crucial role in revolutionizing how training is conducted within our organization.We are looking for someone who thinks beyond the standard of SOPs and can infuse creativity into both GXP and non-GXP training programs. If you have an...
-
Global Quality Assurance Lead
21 hours ago
Copenhagen, Copenhagen, Denmark National Oilwell Varco Denmark IS Full timeOverviewNational Oilwell Varco Denmark I/S is a leading engineering and manufacturing company specializing in subsea production systems for the oil and gas and industrial sectors.We are committed to innovation, sustainability, and operational excellence, providing energy solutions to our clients worldwide.The Director of Quality for Subsea Production Systems...
-
System Test Manager
24 hours ago
Copenhagen, Copenhagen, Denmark PARETO SECURITIES AS Full timeDo you have experience with planning and testing complex systems? At Weibel, you will join a truly technology-driven company that delivers excellent Doppler Radars across the world. Weibel is recognized as a world leader in radar technology, with our radars performing with a precision largely unmatched by competitors. Applications for our radars include...
-
System Solutions Manager
13 hours ago
Copenhagen, Copenhagen, Denmark Emerson Process Management AS Full timeWe are welcoming an experienced System Solutions Manager to join our dynamic team in Denmark. In this role, you will be responsible for driving business growth and development, while collaborating with our local team of sales engineers.As a System Solutions Manager, you will develop and deploy effective sales strategies, facilitate regular sales management...
-
Pharmaceutical Quality Improvement Lead
2 days ago
Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full timeJob DescriptionThe Lean Process Excellence Partner will be responsible for supporting the development and enhancement of QA processes and systems, ensuring compliance with GMP and other regulatory requirements.This role involves:Overseeing and managing the QA project portfolioSupporting and enhancing quality assurance processes through facilitation of...