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  • Location

    Groningen, Netherlands

  • Job title:

    Quality Engineer

  • Sector:

  • Job ref:

    45075

  • Start Date:

    2020-09-29

The Company 
This organisation is a world-leader in the research & development and production of biotechnology and pharmaceutical products. Their main focus is the production of biologic products and vaccines

Role Description 
As a Quality Engineer you will support the product and process development projects, as well as production, in the development of the quality policy and quality systems. 

Responsibilities 
  • Ensuring quality assurance within product and process development projects.
  • Statistical analysis and implementation of statistical process control techniques, sampling schemes and others. 
  • Coordinating specifications for raw and auxiliary materials, processes, semi-finished and end products.  
  • (Co) guiding external (including DEKRA / FDA) and internal audits (CQA)
  • Drawing up and reviewing protocols and reports.  
  • Non-conformity management, change control management. 
  • Continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs. 

Requirements 
  • HBO education in an engineering discipline.
  • 3+ years of experience in the pharmaceutical or medical device industry.
  • Knowledge of GMP, MDD / MDR, QSR CFR 820, ISO 13485, ISO 14971. 
  • Knowledge of quality assurance systems
  • Knowledge of validation of technical systems and processes. 
  • Knowledge of statistics and quality improvement techniques. 
  • Good communication skills in English and Dutch 
  • Availability to work in shifts (3 shifts) 

Other Information 
For more information please contact Carla Garcia at c.garcia@sire-search.com or +31 (0) 20 658 98 01. 
Contact Us

SIRE LIFE SCIENCES B.V.

Staten Bolwerk 1
2011 MK Haarlem
The Netherlands
+31 (0) 20 658 9800

SIRE STAFFING SOLUTIONS B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804

SIRE LIFE SCIENCES DEUTSCHLAND GmbH

Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SINCERE. INTELLIGENT. RESULT-DRIVEN. EXCELLENCE.