Quality Engineer within Life Science
Personality / Commitment
We are looking for a driven and ambitious person with a bachelor of science or equivalent. You are result-oriented, driven and have the ability to work independently as well as in teams. A quick learner is needed for this assignment as the project is ongoing with tight deadlines.
The ability to handle multiple tasks is an additional success factor in this role.
Job / Skills
As a quality engineer you will work proactively with the development team to plan, develop, and deliver medical devices and combination products that are of the highest quality and also satisfies user needs. You will also ensure that the project team follow processes, procedures, ways of working and templates.
As a quality engineer, you will be a link between the QA, Medical Device Regulatory Affairs and the project team and also work with other Quality engineers to drive harmonization across project and execute quality engineering initiatives.
- 5+ years’ experience working in development of medical devices or other relevant regulated industry
- 3+ years´ experience working in a Medical Device Quality or Regulatory department
- Extensive understanding of process for development of Medical Devices and Combination Products; MDD, ISO 13485, FDA 21 CFR 820 and FDA 21 CFR 4
- Experience in establishing DHFs, Technical Files and Dossiers
- Good understanding for medical device technical standards; ISO, IEC FDA guidelines
- Excellent organizational and communication (oral and written) skills.
- Ability to work on teams as well as individually
- Ability to be pragmatic but still be compliant to solve problems
- Good leadership and interpersonal skills
- Good technical and regulatory writing skills
- Fluent in English
At ALTEN we develop and deliver competence for world-leading companies through the most committed engineering and IT consultants. Our customers are found in industries such as Energy, Telecom, Automotive, Defence & Aerospace, Life science and Industry and we are active throughout the whole product lifecycle. As part of the ALTEN Group, we have over 24.000 employees and operations in 20 countries.
It is our belief that genuine commitment is created through possibility of free choice and the opportunity to influence your own personal development. Our business model provides that possibility and this allows us to offer our customers the most committed consultants, regardless of assignments.
I look forward to your application!
Contact person: Group Manager Simon Levén, +46723 532 465
Ansökningstiden : 16/05/2018
Kontakt : Simon Levén
Region : Sweden - Västra Götaland - Gothenburg