Overview
SENIOR QUALITY ASSURANCE SPECIALIST FOR °MEQU Jobs in Copenhagen, Capital Region of Denmark, Denmark at ˚MEQU
Title: SENIOR QUALITY ASSURANCE SPECIALIST FOR °MEQU
Company: ˚MEQU
Location: Copenhagen, Capital Region of Denmark, Denmark
Senior Quality Assurance Specialist for °MEQU
Join a fast-growing MedTech scaleup
This is an exciting opportunity to join °MEQU during a period of exiting growth and development. We are looking for a highly motivated and experienced Medical Device Quality Specialist to play a key role within our QA & RA Department.
Seize this opportunity if you want to be part of our dynamic team in Copenhagen and help us shape the future of critical care.
ABOUT °MEQU
At °MEQU we empower healthcare professionals to save lives with our innovative °M Warmer System; a sterile portable blood and intravenous (IV) fluid warmer that heats fluids to body temperature within seconds. The system is trusted in the most demanding environments, such as military forces, emergency medical services, rescue helicopters, and hospitals globally. We achieved CE-marking in 2018 and U.S. FDA 510(k) clearance in May 2024. As we continue our growth and expand into new markets, we are committed to delivering cutting-edge, user-friendly healthcare solutions.
We have offices at Symbion, Fruebjergvej 3, 2100 Copenhagen.
The role you will fill
As our new Senior QA Specialist, you will be part of QA & RA Department and report to the Chief RA/QA Officer in °MEQU. The position involves responsibility for specific QA processes, ensuring the operation, continuous development, training of the organization, etc.
The company complies with the following overall Quality Management System requirements for Medical Devices: ISO 13485:2016, MDD/MDR, FDA, UKCA, TGA, Japan MHLW MO169
THE POSITION
As a Senior QA Specialist, your will be process responsible for specific QA processes:
- The complaint process, including coordinating RA involvement in relation to reporting to the authorities and the investigations in close corporation with R&D and Operations. It will also involve ensuring input to Post Market Surveillance Process.
- Manage the non-conformity and CAPA processes by collaborating cross-functionally to ensure timely investigations, effective root cause analysis, and successful implementation of corrective and preventive actions.
- Ensuring input to Quality Management Review process, including conducting trend analysis and evaluation.
- Batch Release
- Preparing and performing internal audits and supplier audits.
- Acting as QA partner for R&D for Design Control and Design Change Project, cost saving projects and development of the next generation of products. This includes the Risk Management Process
- Support the implementation of an electronic document management system for specific QA-processes
- The job will also include updating and maintenance of quality documentation, such as procedures, instructions, and forms – including continuous process improvement and training of the °MEQU organization in both general and specific QA processes and subjects.
ABOUT YOU
You have several years of experience from a similar position within QA, ideally from a company within the Medtech business. You are now ready to join a young and vibrant MedTech scale-up company and contribute to the fast development of your own area of responsibility as well as the cooperation across the organization.
We expect:
That you hold a degree in Engineering, Master of Science, or a similar technical education in a MedTech relevant field
You have experience from a QA position within medical device development and have a strong understanding of the relevant compliance requirements.
As a person, you enjoy working independently, trying new things, and managing a working day with deadlines and changeability.
It will be an advantage if you know the requirements for working in a set-up with contract production, as well as sterilization and production in clean rooms, and experience with electromedical devices.
°MEQU is characterized by a strong culture of cross-functional collaboration and a striving to constantly optimize working processes. You will work closely with colleagues in RA/QA, R&D, Operations, Sales and Marketing.
Since the company is undergoing development with increased growth, it must be expected that the job description can be continuously adjusted with more and/or other tasks.
APPLY
An external HR Specialist will be involved in the recruitment process.
Send your CV and application to [email protected].
OR use the APPLY function.
For more information about the recruitment process, contact: Nils Munck +45 53573274
For questions related to the position, contact Laila Lundtoft +45 20808397
We ask you to apply as soon as possible: we will be conducting interviews with candidates on an ongoing basis.
