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At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way. We move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people’s lives. 

To support our exceptional teams who develop great medical technology products and contribute to our growth, we are looking for you as Product Quality Engineer - Medical (a) for our Flex site in Hägglingen / AG.

In this role, you will report to the Head of Quality, support the Product Quality Engineering Manager and act as a point of contact for customers and suppliers regarding product quality.

Product Quality Engineer - Medical 100% (a)

Here is a glimpse of what you’ll do:

  • Ensuring compliance with quality requirements for medical devices and product conformity in the event of changes (change control);
  • Working independently in the area of deviation and change management and supporting the continuous development of our quality management systems;
  • Creation of 8 D reports including CAPA's in the system and as CAPA responsible for the assigned products/customers;
  • Creation and coordination of qualification and validation plans for existing and new products, processes and lines together with our customers, as well as independent implementation of qualifications and validations;
  • Planning and implementation of requalifications and revalidations, as well as investigating product complaints and determining suitable measures;
  • Coordination and implementation of FMEAs and statistical analysis of data sets and key figures;
  • Participation in internal and external audits by customers and authorities;
  • Creation of requirements catalogs, control plans, master validation plans;
  • 10% travel to the Küssnacht site.

Your experience with which we want to strengthen our team:

  • A completed education (university, FH, TS, or comparable);
  • Ideally experience in regulated industries and with process methods such as MDD/MDR, EN ISO 14971, 21 CFR 820 (QSR), GMP, etc;
  • Practical experience in the application of quality and problem solving techniques;
  • At best, initial professional experience in the field of qualification / validation technology and with a focus on injection molding technology is an advantage;
  • Ability to work in a team, willingness to learn, proactivity and flexibility;
  • Good PC skills and confident working with common office applications (Word, Excel PowerPoint);
  • Experience with statistics, ideally with statistical software such as Minitab is an advantage;
  • Very good written and spoken German and business fluent English are required;
  • Strong communication skills and networked thinking;
  • Willingness to travel sporadically within Switzerland.

Here is some of what you get for your good work:

  • Extensive induction training;
  • Professional and modern working environment;
  • E-Charging stations;
  • Access to personal and professional development;
  • A competitive salary package.

Please note that our recruitment team is based in Austria and therefore you may be called by an international number (+43...).

We look forward to receiving your application!

Further Information

sarah.hutzfield@flex.com

www.flex.swiss
Apply now