Quality Enginer / Combinational Devices (m/f)
Quality Engineer – Growing Medical Devices / IVD Company

 
     
 

Sysmex Partec is the newly formed collaboration between Partec, a worldwide leading pioneer, developer and manufacturer of flow cytometry systems and Sysmex Corporation, a leading international supplier of in vitro diagnostic products. As part of the multinational group of companies with more than 7.000 employees worldwide. In Görlitz are employed about 170 employees. We are looking to support our team to expand our activities and of course our dynamic company development.

 
 
Responsibilities:  
  • Ensuring the quality aspects of introducing new products
  • Support of qualification, writing SOP´s, QMS
  • Process validation
  • Reporting and investigation of Complaints / Adverse events
  • Trending of critical process parameters
  • Product Quality Review
  • Participation in development projects and production optimization
     
Requirement:  
  • Suitable candidates would typically be degree qualified in a relevant discipline such as the natural sciences, pharmacy or medicine, with at least 5 years of production experience (mass production, lean production, automation technology and plastics technology)
  • Experience in medical technology/devices is a must (including training, process - and design validation, GMP regulatory requirements, processing of variation, data analysis, risk management, statistics)
  • Hands on experience with production of combination products is a huge bonus for 1 of 3 positions available as is experience in Six Sigma.
  • Travel as required
  • Fluent English is mandatory
  • German native
     
Conditions::  
  • 40 hours per week
  • Please name us your salary expectation
  • Place of action Görlitz
 
     
 

Please send your application preferably on:
jobs@sysmex-partec.com

 

or alternative to:
Sysmex Partec GmbH – Human Resources – Am Flugplatz 13 – 02828 Görlitz