QA / R&D Specialist for Medical Device Development
Be a part of an energetic and innovative company and help us develop future products for our clients, particularly within Medical Device and Pharma industry.
As a QA Professional at Technolution you will experience exciting and versatile everyday tasks in various industries and disciplines. You will work either as a consultant at the client’s premises or from our office in Hørsholm and always in cooperation with your colleagues in Technolution – and often in the interface between R&D and QA. The projects vary in size and duration, and you will experience a varied job with an extensive contact to the industry.
Typically, you will participate in:
- Product development teams where your responsibility is to meet regulatory requirements and where you will participate in the preparation of documentation.
- Preparation of Technical File for CE submission.
- Continuous improvement of our ISO13485 QMS, including ISO 14971 and IEC 62366.
- Establishing and maintaining the procedures, forms, tools and methods we use in our daily work.
You have experience with medical device development and design control. You have participated in 2-3 development projects, either as an R&D professional with knowledge of design control or as a QA professional with profound involvement in the implementation of development projects.
- You might have a background as an engineer or similar.
- It will be an advantage if you have knowledge of ISO 13485, IVDD and 21 CFR Part 820.
- As a person, you see opportunities, have great cooperation skills and a structured approach to your work, take responsibility and meet deadlines.
- You communicate fluently, both orally and in writing, in Danish and English.
WHAT WE OFFER
You will have extensive contact across industries and disciplines, and you will be a part of a company where professionalism and unity are keywords. We have regular events of both professional and social nature and strive to create a safe, trusting and developing corporate culture. We take pride in our unpretentious and professional company environment where we know each other well and we are good at making room for the individual and sees the strength in being there for each other. We are always open to be inspired by your contribution and you will have plenty of opportunities to contribute to the continuous improvement of Technolution. We offer attractive working conditions, which among other things, includes a health insurance.
Click here to learn more about Technolution.
We look forward to hearing from you
Please send your application and CV directly on our website, or by email to firstname.lastname@example.org. Applications will be handled continuously.
If you have questions, please contact Allan Spork tel. +45 40 45 10 01.
Technolution is a growing consultancy company working on many exciting projects. We help our clients in the development of particularly Medical Devices and instruments and handle the entire development process in-house according to current standards such as ISO 13485/9001. Technolution focuses on the Pharma, IVD and Medical Device industry both in Denmark and globally. We have room for individuality, a flat organisation structure and expect everybody to take responsibility. Our office in Hørsholm is large with bright rooms, great facilities, prototype workshop and Test Lab. Drop by for a cup of coffee, and we will see if we can give your career a boost.