Quality Assurance Manager - Maastricht

Vacancy information

Publication date:May 01 2020
Employment type:Permanent
Sector:Medical Devices
Function Group:Quality/RA

Function Group: Quality/RA / QA Manager

Organization

For an organisation active in devices using natural ingredients, we are searching for a Quality Assurance Manager. This organisation is specialised in wound-related devices and is partnered with an international organisation. They sell their products in over 60 countries world-wide.

Because of the COVID-19 crisis, they have started a new production line of FFP 2 face masks to help with the world-wide shortage. This is next to the usual production activities. This has resulted in an interesting combination of devices being developed at this organisation.

Function

Because of the development of the new production line, in combination with the yearly innovations this organisations brings to the market, this role as Quality Assurance Manager is very diverse. In short, the three main responsibilities of this role are: product innovation/development, third party management, and promoting the QMS (QA/QC). In addition, you are responsible for regulatory related activities.

Tasks related to these responsibilities are as follows:

  • Guarantee, evaluate and improve the quality standards in the organisation according to ISO13485
  • Continuous improvement of the products and systems
  • Working on new innovations and therefore product development
  • Ensure the existence of the required certificates and quality documents for the wound care products
  • Being responsible for the release of products
  • Following-up and maintaining the ISO13485 QMS for the production of FFP2 face masks
  • Executing the needed quality tests
  • Following developments related to regulations and registration

Requirements

The ideal candidate has:

  • A Bachelor in a life sciences related field
  • At least three years of experience in quality management in an ISO13485 environment
  • Experience and strongly interested in product development, in relation to Quality Assurance (QA)
  • QA supplier mamagement experience
  • Basic knowledge on Regulatory Affairs (RA)
  • A proactive mindset and able to act fast in on QA topics
  • Strong communication skills and has the ability to to challenge the CEO in the right direction

Offer

This role gives you the chance to:

  • Make a difference in the COVID-19 crisis
  • Have strong influence on an internationally operating organisation
  • Earn a salary of €40,000-€65,000 gross per year, depending on experience

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Consultant Quality & Clinical | Medical Devices

+31(0)6-13143973
+31(0)23-7548660
s.cepella@qtcrecruitment.com

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