Kvalito consulting group life science consultant - device technical expert- junior

1. We are Looking for Medical Device Experts!
KVALITO Consulting Group is a strategic life science partner with
global quality and compliance service network for the regulated life
science industry. Headquartered in Basel (Switzerland) with
subsidiaries in Prague (Czech Republic), Dresden (Germany) and Dublin
(Ireland)
Responsibilities:
Responsibilities
 Ensure product compliance for assigned projects
 Compile Design Control documentation and contributing to a high
quality Design History file (DHF).
 Establishes/Participates in the documentation strategy
 Support of development of Quality Assurance Agreements with third
parties.
Minimum Qualifications and Experiences
 Master degree in Science/Engineering or Mechanical Engineering or
University level Engineering education.
 Excellent skills in English language are required.
 The successful candidate for this position will support technical
activities within the development of parenteral delivery systems,
e.g. drug/device combination products and medical devices.
Preferred Qualification and Experiences
An ideal candidate would have a relevant degree in engineering and at
least 5 years of experience in a similar area, including:
 Pre-filled-syringe device development, from early phase
activities up to commercialization and production scale-up;
 Medical device quality assurance;
 DHF compilation, including Design Control process and other
applicable regulatory, QA and GMP aspects;
 Understanding of medical device regulations (FDA 21CFR 820, EU
Medical Device Directive);
Life Science Consultants
Device Technical Expert - DHF

2. We are Looking for Medical Device Experts!
 Background in mechanical engineering in general
o Product design/Design for manufacture
o Test and verification, incl. development of methods and
equipment
 Experience in medical device quality assurance;
 Good communication and conflict solving skills;
 Good technical knowledge in primary containers, e.g. syringes and
cartridges;
 General understanding of pharmaceutical development ;
 General understanding of Human Factors Engineering and Risk
management.
We offer great benefits
 Flat hierarchies and responsibility from the beginning
 People-oriented culture
 Diversity and inclusion focused environment
 Global client projects in a multinational environment
 Flexible working hours and home office
 Involvement in global conferences
 Individual professional development, training and coaching
 Laptop and mobile phone
 Vacation/Leave
 Unlimited full employment contract
 Excellent remuneration package with a monthly salary plus a
substantial bonus
Contact
If you have the necessary background and experience and would like to
join a small team responsible for a truly global operation, then please
send your application to info@kvalito.ch including:
 Your CV
 A motivation summary (max. 5 sentences)
 The earliest starting date
 Your salary requirements
 Your availability / earliest start date

3. We are Looking for Medical Device Experts!
 Your preferred locations (Basel, Dublin, Prague, Dresden)