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Quality Assurance Engineer ze znajomością IVD Medical Devices regulation

AVANTOR PERFORMANCE MATERIALS POLAND SAAbout the company

AVANTOR PERFORMANCE MATERIALS POLAND SA

Generała Józefa Sowińskiego 11

Gliwice

Your responsibilities

  • implementation of the quality policy in compliance with current IVD MD requirements

  • initiating, recommending and controlling actions aimed at ensuring appropriate quality and effectiveness of the company’s system in the IVD MD area

  • maintaining quality records concerning IVD MD products

  • preparing reports on functioning of management systems and any needs related to the improvement of those systems in the area of IVD MD

  • preparing reports (weekly, monthly)

  • maintenance of site documentation concerning IVD MD products up to date

  • supervising the archive of quality documentation

  • cooperation in the scope of introducing IT system modifications according to the needs

  • planning, organizing and conducting audits conducted in the Company

  • preparation of and participation in audits and inspections taking place in the Company

  • participation in the work of task teams appointed by the President of the Board

  • conducting and participating in other company projects

  • development of repair action schedules, ongoing verification of their progress, approval of CAPA and MOC documents

  • supervision over the activities related to the Quality Review

  • archiving the Company’s documents provided for in the procedures

  • conducting corrective and preventive actions aimed at protecting the Company’s interests

  • performing other activities resulting from detailed provisions of the Quality Assurance System documentation binding in the Company

  • implementation of the tasks within the scope of quality objectives set

  • supervising the performance of qualitative indicators

  • support for validation processes

  • conducting complaints procedures concerning the area of quality assurance

  • coordination of Change Management process

Our requirements

  • experience in IVD Medical Devices regulations is a must

  • university degree in area of chemistry or quality systems

  • fluent English knowledge

  • min 5 years experience in production environment – the best of it is pharma related

  • proven ability to lead the project ( PRINCE would be nice to have )

What we offer

  • Private medical healthcare

  • Additional life insurance and social found access

  • Sport card (Multisport)

  • Food vouchers to our canteen and free beverages

  • Benefits

  • sharing the costs of sports activities

  • private medical care

  • life insurance

  • remote work opportunities

  • drinks

  • extra social benefits

  • meal passes

AVANTOR PERFORMANCE MATERIALS POLAND SA

We set science in motion to create a better world.

From discovery to delivery, we are a trusted global partner to customers and suppliers in the life sciences, advanced technologies & applied materials industries.

Quality Assurance Engineer is accountable for providing management and maintenance of GMP and IVD Medical Devices products.

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