Job: Quality Management System Specialist (part time)
Part-time job as a Quality Management System Specialist for Medical Device Development company
Be part of an energetic and innovative company and help us develop future products for our clients, particularly within the Medical Device and Pharma industry.
As a Quality Management System Specialist at Technolution you will be part of a small, competent and dedicated QMS team, where your primary responsibilities will be:
- Maintaining and participating in improving our QMS – certified ISO 13485 / ISO 9001
- Participating in maintaining the ability to comply to ISO 14971, IEC 62366 and other standards
- Perform internal audits and external supplier audits.
- Participation in Notified Body audit(s) of the Technolution QMS.
Your primary workplace will be at our office in Hørsholm, but you might also be involved in customer projects at the customer’s premises.
Working hours per week: 20-30
You are experienced in working – in detail – with ISO 13485 and ISO 9001 standards and preferably other standards within Medical Device/Pharmaceuticals. You have a profound understanding of the interpretations and possibilities for implementing QMS system(s) into a business for optimal value to the company.
It will be an advantage if 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.
- You have in-depth knowledge and experience of ISO 9001, ISO 13485, 21 CFR Part 820 and preferably IVDD.
- You have experience from both Medical Device R&D and manufacturing.
- You are a trained and skilled Auditor.
- As a person, you have a structured approach to your work, take responsibility, see opportunities, have great cooperation skills and meet deadlines.
- You communicate fluently, both orally and in writing, in Danish and English.
WHAT WE OFFER
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 see 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 Quality Manager Marianne Lind at email@example.com
Application deadline June 30th 2017. Applications will be handled continuously.
The position is expected to be occupied as soon as possible.
If you have questions, please contact Marianne Lind tel+45 20 73 57 41.
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.