Risk and Validation Quality Engineer- Medical Devices

Novocure

Krakow, Poland

To support our team in Krakow, Poland we are looking for an: Risk and Validation Quality Engineer.

The primary responsibilities include managing quality aspects of Novocure’s process and equipment validation programs. Ensure validation programs meet requirements of FDA and ISO, and process compliance. Along with the execution and planning of internal and external validations, this position will also be responsible and accountable for the execution of the requirements related to the Risk Management activities. This position will maintain and regularly update the pFMEA and relevant documentation, identifying the risks and proposing/implementing mitigations.This position will also support internal audits at specified intervals and report audit findings, promote continuous improvement of systems, products, and services.

Your responsibilities:

Responsible for creation of high level test plans, oversee its progress and completion
Responsible to review and approve test methods, validation test plans and results.
Responsible for Validation samples management
Act as a point of contact for subcontractor test laboratories
Participate and support Novocure Global PM program implementation (SW)
Conduct of internal audits per annual program
Relevant Issue/NCMR/CAPA management

Your profile:

University degree in a scientific discipline or related Engineer/Science qualification (Minimum BSc and preferably Electronics) with a minimum of 3 years working as a quality engineer in a multi-national medical device manufacturing & distribution environment.
Proficient with qualification / validation of test methods and manufacturing processes including equipment used for validation/ verification/manufacturing.
Proficient in utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, etc). A Six Sigma certification will constitute a preferential title.
Proficient in planning and overseeing execution of product validation studies (pharma and/or medical device industry experience is a must).
Application of quality regulations and standards (21CFR 820, ISO 13485, MDR is preferred).
Excellent English, as the primary working language

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