Would you like to be part of a team ensuring the highest levels of patient safety? You will be contributing to the development and approval of intelligent and innovative treatment methods within the medtech industry.
Medicologic is a leading Danish medtech consultancy and engineering company. Together with our customers we bring new and innovative products on the market on time.
We are growing and thus need additional resources.
With a strong pipeline of challenging projects we are seeking a passionate Quality Consultant to join our QA/RA team in Copenhagen. Reporting to the Team Manager you will be part of our RA & Quality team; interact with customers to solve hands-on QA assignments.
You will support customers with relevant QA activities from development of entire Quality systems to maintenance and support of specific procedures.
Bringing customer products to the market require that you have solid competences in creation of relevant documents needed for CE-marking. This might be risk management, usability testing, product verification, process validation or other relevant activities.
Maintaining and improving our own ISO13485 certification will also be part of the job.
Being a trained and skilled Auditor is an advantage; we offer to perform Audits at customers or 3. Party Audits.
The ideal candidate is currently working for either one of the leading manufactures’ of medical devices or potentially with one of the other significant consultancy firms within Medical Device Development in Denmark or Sweden.
Desired Skills and Experience
Our preferred candidate has the following professional and personal qualifications:
• Relevant education degree (B.Sc. or M.Sc.)
• Minimum 5 years of experience in relevant positions
• Post-market surveillance experience
• Knowledge of ISO13485 and documentation of medical devices, Skills in creation/maintenance of Quality Management Systems.
• Experienced with process equipment and software validation
• Knowledge of apps in medical industry is an advantage
• Training and teaching experience is an advantage
Competencies (professional and personal)
• Solution oriented with an excellent ability to identify a cost-effective approach to quality assurance assignments
• Have a strong collaborative approach towards stakeholders
• A good listener with strong communicative skills
• Strong cultural awareness and a global mindset
• Fluency in English and one other Scandinavian language
• Outgoing personality with skills to facilitate and lead projects
We offer a challenging environment with build in opportunities for growth both professional as well as personal. We are a company with growth potential and concrete growth plans. Our customer centric approach to consultancy gives you an insight into cutting edge development both in Denmark and internationally.
We would like to welcome you in our engaged, warm, positive, fast and professional environment with social events amongst colleagues as well as professional sparring from highly experienced experts in order for you to have an engaged daily work experience as well as professional growth opportunities while working. Also we offer a competitive compensation package with both pension and insurances.
If you want to know more about the job you are welcome to contact CEO, Michael Funder on +45 2064 4146 or firstname.lastname@example.org
Send your application
Send your application including CV to CEO, Michael Funder email@example.com.
We look forward to hearing from you.