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
 Definition of manufacturing process, process verification and
validation and process/tool validation at contractor (cpk,
manufacturing assessment etc); including definition verification
and validation of device sterilization process;
 Compile documentation on device manufacturing;
 Manufacturing process scale-up and technical transfer;
 Lead and run process FMEAs.
 Planning and leading technical activities;
 Creating Design Control documentation and contributing to a high
quality Design History file;
 Definition of product requirements for delivery systems;
 Managing technical development activities in collaboration with
internal development partners;
 Leading the collaboration with external development partners:
o Monitor work progress according to plan
o Monitor, support and challenge technical development as well
as test and verification work
o Monitor development and implementation of manufacturing
processes
o Coordinate and monitor technical documentation
 Evaluating and challenging technical solutions;
 Leading or participating in Risk management activities;
 Supporting Human Factors Engineering activities;
 Supporting and coordinating the manufacturing of clinical
material and the production scale up.
Minimum Qualifications and Experiences
Life Science Consultants
Device Technical Expert – Device Manufacturing

2. We are Looking for Medical Device Experts!
 The successful candidate for this position will lead or support
technical activities within the development of parenteral
delivery systems, e.g. drug/device combination products and
medical devices, within the Device Team with main focus on
parenteral, from early phase activities up to commercialization
and production scale up.
 A strong technical background in devices and primary containers
for parenteral is crucial, in order to support, monitor and
challenge internal and external development partners.
 Master degree in Science/Engineering or Mechanical Engineering or
University level Engineering education
 Excellent skills in English language are required. Proficiency in
German advantageous. Other language skills, e.g. French,
advantageous.
Preferred Qualification and Experiences
An ideal candidate would have a relevant degree in engineering and at
least 7 years of experience in a similar area, including:
 Manufacturing process development and validation;
 Pre-filled-syringe device development;
 Device sterilization process development;
 Mid-Early stage activities e.g. Design verification testing,
design for manufacturing (prototype to model, manufacturing
feasibility).
 Late stage activities e.g. tool qualification; equipment
qualification;
 DHF compilation;
 Development and documentation of drug/device combination products
and medical devices, including Design Control process and other
applicable regulatory, QA and GMP aspects;
 Experience of managing external suppliers;
 Experience in ophthalmic application systems
 Good communication skills;
 Good training and presentation skills;
 Good technical knowledge of parenteral packaging and medical
devices;

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