We are currently partnering with UNEEG medical an innovative medical device company looking to recruit a Senior Process specialist to join their internal team in Allerød.
As a Senior Process Specialist, you will be responsible and ensure the principles for design control within UNEEG medical Quality Management System (QMS). You are highly motivated by optimizing and improving processes in collaboration with key stakeholders within the organization. You take pleasure in supporting and communicating to internal stakeholders how to adequately use the design control principles in product development and product sustaining projects. You will be the subject matter expert (SME) within Design control, which mean that you will be the go-to person and train colleagues in the principles and related design control procedures. You are familiar with the whole lifecycle for medical devices, understands how the technical documentation is built and preferably have hands-on experience with records from the technical documentation.
Key responsibilities include
The Senior Process Specialist for UNEEG medical will be a key person within the system engineering team of 7, working in close cooperation with the team and internal stakeholders. You are motivated by being the Subject matter expert within Design control and has good experience from previous positions on how to implement, communicate and execute the activities related to the area. Your mindset is pragmatic, quality orienteered and preferable with a high level of process structure. You find pleasure in training and teaching others, so the design control principles will become a more integrated part of the development projects. As the SME for design control, you will take part in audits.
– Master’s or bachelor’s degree in engineering or related
– Extensive knowledge of ISO13485, Medical Device Regulation 2017/45, FDA21 CFR part 820
– Experience with risk management per ISO14971:2019 – preferably also hands-on
– Excellent communication skills
– Hands-on experience with design control and writing QMS procedures
– You have an analytical and structured approach to your work, but at the same time, you are open-minded and see possibilities
– You are a team player, but appreciate responsibility and to work independently
– You are proactive, good at prioritizing, planning, and finalizing your tasks.
– Ideally you have experience with products that contain both hardware and software components
UNEEG medical A/S was founded in 2005 and is an entrepreneurial and ambitious company pioneering cognitive technologies that collect, monitor, and analyse brain activity (EEG). The device can be used for medical and diagnostic purposes within epilepsy ad detect and alert diabetics of severe hypoglycaemia, hence aiming at improving patients’ quality of life. UNEEG medical employs approximately 90 people.
For further information do reach out to Head of Recruitment Ida Wenger-Parving on 2633 4301 or apply directly here. Due to GDPR, we cannot receive any CVs via e-mail. Interviews are already taking place, so please get in touch or apply at your earliest convenience.
Read more about Senior Process Specialists here!