For our Quality Department, in our company site in Novazzano, Switzerland, we are looking for a Quality Assurance Engineer SR who is responsible for :
Support the company conformity to the FDA 21CFR part 820 regulation and to the Medical Device European Directive(s) / Regulations and following quality management systems standards : ISO 9001 / 13485
Support the company for environmental, health & safety management system : ISO 14001 / 45001
Support the company on designing and improving the cross-functional processes
Support the Management Review process and Enterprise Risk Management
Draw up procedures and instructions for Integrated Management Systems.
Partecipate to the continuos improvement projects and compliance projects (e.g. IVDR).
Manage the CAPA, Process Non-conformities and enhancements
Support the quality team during internal audits and the third and second party audits.
We are looking for a candidate with these skills :
Project Management methods
ISO 9001 / 13485
IVDR 2017 / 746 knowledge / experience
21 CFR 820
Capability to summarize and discuss critical matters with middle level managers
Analytical critical problem setting and solving skill
Capability to independently manage projects or problems.
Capability to provide sustainable solutions in compliance with regulation / standards.
Good Communication skills
Capability to manage the conflicts
English B2 level
What we offer :
a dynamic work environment where you can make a difference and grow your career;
an international work location in our headquarter in Switzerland (Novazzano);
flexible working hours ;
working time account : possibility to accrue additional hours of free time in addition to holidays;
additional contribution to the pension fund ;
professional and non-professional accident insurance;
company restaurant for the lunch break;
incentives for mobility by public transport;
agreements for bank account, credit card and personal purchases;
opportunity of professional and salary growth through various initiatives :
annual performance appraisal in order to evaluate the achievement of individual objectives;
inner job posting to apply for career opportunities in Inpeco, even between different locations;
annual salary review linked to performance and professional development;
continuous training on the job, through meetings or conferences, seminars and events