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  • Location

    NOORD-BRABANT, Netherlands

  • Job title:

    Senior QA Engineer

  • Sector:

  • Job type:

    Permanent

  • Job ref:

    44493

  • Start Date:

    2020-07-07

The Company

Our partner is active in the development of highly innovative life-changing products.

 

Responsibilities

  • Test method validations and process validations.
  • Release of products for clinical studies.
  • Review technical reports and design documentation.
  • Manage structural improvements in the QMS. 
  • Introduce and implement the quality processes and tools required to ensure product quality. 
  • Provide training for relevant QMS Management areas.
  • Manage and perform internal and external audits.

 

Requirements

  • Minimum Bachelor Degree in technical area or other relevant scientific field.
  • Minimum 5 years of industry experience.
  • At least 2 years of experience in medical device
  • Broad working knowledge of ISO 13485, ISO 14971, FDA QSR, EU MDD, EU MDR.
  • Experience with test method validations and process validations.
  • Experience in root cause analysis, corrective and preventive actions.
  • Experience with risk management.
  • Experience in writing and maintaining Quality Management System procedures,
  • and providing training on them.
  • Good knowledge of and experience with Quality Assurance & control methodologies.
  • Experience with internal and external audits.
  • Pragmatic approach to problem-solving.
  • Able to work per priorities and tight deadlines in a fast paced, time sensitive environment.
  • Good communication, reliable, independent, goal-oriented, pragmatic attitude.
  • Strong organization skills.
  • Fluent in English, reading and writing.
  • Experience with statistical software, e.g. Minitab is preferred.

 

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.