Head of Quality Management (m/f/d)

Visotec GmbH • Lübeck

  • Full-time

Lübeck
from today

Your responsibilities

The Head of Quality Management is responsible for the quality management system of VISOTEC GmbH and its effectiveness and performance, with direct reporting to the management.
  • Accompanying the development projects incl. carrying out milestone reviews
  • Responsibility for document control (change management of the QMS)
  • Preparing and carrying out the management review,
  • Creating and maintaining the computer system validation master plan and carrying out the validations
  • Supplier Quality Management,
  • Planning and carrying out internal and external audits (at suppliers or by notified bodies and authorities) by notified bodies and authorities) 
  • Communication with and contact person for the notified body
  • Establishment of CAPA management
  • Establishment of complaint management
  • Establishment of product risk management
  • Maintenance and further development of the quality management system implemented at VISOTEC in accordance with the certified ISO 13485 standard and the regulations of the countries and markets participating in the MDSAP
  • Creation and optimization of workflows and processes within the quality management department 
  • Creation of quality planning relevant to the company

Your qualifications

  • Completed training or technical/scientific studies
  • Several years of professional experience in setting up and expanding QM systems at a medical device manufacturer with products in risk class IIa/b
  • Proven experience in organizational development and leading through change processes 
  • Experience in employee management 
  • Qualification as quality manager or quality auditor
  • Audit experience (internal and supplier)
  • Experience in CAPA management
  • Experience in regulatory affairs
  • Experience in process management
  • Very good MS Office skills (Word, Excel, PowerPoint, Visio)
  • Confident written and spoken German and English skills

Your profile

  • High sense of quality and responsibility 
  • Strong interpersonal skills as well as good communication skills and a confident manner
  • Ability to work in a team and strong negotiation skills
  • Solution-oriented and accurate way of working
  • Goal- and action-oriented working style
  • Strong hands-on mentality
  • Analytical skills

We offer

- Small, motivated team with a flat hierarchy
- Opportunities for mobile working to achieve a good work-life balance
- Flexible working hours on a basis of trust
- Fitness allowance for Urban Sports Club
- Attractive, performance-oriented remuneration
- Further education and training opportunities

Our benefits

Employee jubilees:

To show our appreciation, we reward our longstanding employees for company anniversaries and retirements.

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