Quality Assurance Engineer SR
Novazzano Switzerland
4d ago


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.
  • Requirements

    We are looking for a candidate with these skills :

  • Project Management methods
  • ISO 9001 / 13485
  • IVDR 2017 / 746 knowledge / experience
  • 21 CFR 820
  • Audit techniques
  • 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);
  • home office;
  • 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;
  • car pooling;
  • 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
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