Job: Design Control Specialist
Design Control Specialist for Medical Device Development
Together with our team of QA specialists and development engineers, you will be responsible for the preparation of the documentation for new medical devices.
As a Design Control Specialist at Technolution you will work in the interface between R&D and QA to assist development teams to e.g. plan, facilitate and prepare the risk management documentation, the usability engineering documentation, the specifications and to plan and prepare the verification documentation.
You will work either as a consultant at the client’s premises or from our office in Hørsholm and always in cooperation with your competent and dedicated colleagues in Technolution. The projects vary in size and duration, and are either projects conducted according to the customers QMS or according to our ISO 13485 QMS.
Typically, you will participate in:
- Product development teams where your responsibility is to meet regulatory requirements and where you will participate in preparation of the documentation.
- Preparation of Technical File for CE submission.
- Continuous improvement of our ISO 13485 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 a R&D professional with knowledge on design control or as a QA professional with profound involvement in the implementation of development projects.
- 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.
- It is important, that you have a hands-on approach.
- You communicate fluently, both orally and in writing, in Danish and English.
WHAT WE OFFER
You will be part of an energetic and innovative company and help us develop future products for our clients, particularly within Medical Device and Pharma industry. 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 by email to Managing Director Allan Spork at firstname.lastname@example.org.
Application deadline July 14th 2017. Applications will be handled continuously.
For further information on the position, please contact Allan Spork or Michael Mikkelsen 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.