About The Role

This position is responsible for tactically managing quality requirements between Nextern and key customers, ensuring customer quality expectations and daily requirements in engineering, production development, and supply chain, balancing responsibility between areas to achieve product quality performance and in compliance with company requirements and regulatory agencies and customer guidelines.

Lead complaint and CAPA investigations.
Communicate with external and internal clients directly.
Perform internal audits.
Lead changes to QMS documents.
Lead validations, TMVs.
Execute IIR and FAIR reports with no support.
Provide support to engineering activities from other areas, such as IQs, OQs, PQs
Performs new product introduction activities; support for the execution of these tasks may be required.
Support quality activities for product development and transfer.
Provide mentoring in Investigations and Root Cause Analysis tools.
Provide support to other engineering areas with minimal or no support from another area.
Participate as Quality leader in development projects

Requirements

Bachelor´s degree in engineering or a life sciences-related major, desirable a postgraduate degree in related areas.
5 years of engineering/quality experience in a highly regulated manufacturing/industry environment.
English level C1, B2
Must demonstrate value adding competencies at establishing collaborative relations, operational excellence and agile decision making, and also show high competency level in people development.