QMS Manager m/f/d

Date: Jul 22, 2021

Location: Prague, Czech Republic, CZ, 500 03

Company: Heraeus

QMS Manager m/f/d
Location Hradec Králové
Full Time

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of around 14,800 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.


Roles and Responsibility:

•    As QMS MGR you will be responsible for QMS compliance with the requirements (EN ISO 13485, US FDA 21 CRFR 820, EU Medical Directives)
•    Manage the system of internal auditing and supplier (incl.evaluation of suppliers, classification and qualification)
•    Consulting and guidance to our customers (incl.quality agreements)
•    Leading  audits of Regulatory authorities and customers, ensuring that all corrective action are effective and closed
•    Be trainer on quality system related activities for our team and other staff 
•    Support the entire Quality department in trending of KPI
•    CAPA administrator (review of plans, actions and effectiveness check)


What is required for this role:

  • You have successfully completed University
  • Experiences with Quality Management System (ideally ISO13485)
  • Experiences in this field at least 5 years (f.e. in regulatory/quality assurance, medical devices, pharmaceuticals, biotechnology)
  • Advantage is knowledge of medical devices nad related regulations
  • Furthermore, you are well-organized, independently working and communicative person
  • Able to work collaboratively across the team and cross functionally
  • Excellent written and verbal communication skills in English
  • Very good PC skills