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. This role will have supervisory responsibilities of technical and professional levels, defining strategies and providing mentorship on technical issues to direct reports. Among main responsibilities are to:
- Lead complaint and CAPA investigations.
- Communicate with external and internal clients directly.
- Perform internal audits.
- Lead changes to QMS documents.
- Lead multidisciplinary groups for high complexity projects.
- 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.
- Lead Quality activities for product development and transfer.
- Provide mentoring in Investigations and Root Cause Analysis tools.
- Provide support to other engineering areas with mínimal or no support from another area.
- Participate as Quality leader in development projects and perform NPI activities.
- Guide as a mentor to lower levels for technical topics.
**Requirements**:
- Bachelor´s degree in engineering or a life sciences-related major, desirable a postgraduate degree in related areas.
- 6-8 years of engineering/quality experience in a highly regulated manufacturing/industry environment.
- Vast experience in sustaining lines and supervisory roles
- English level C1
- Must demonstrate value adding competencies at establishing collaborative relations, operational excellence and agile decision making, and also show high competency level in people development.
**Benefits**
Competitive compensation package and optimal working environment.