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.
Benefits
Competitive compensation package and optimal working environment.
Skills Required
- Bachelor´s degree in engineering or life sciences
- 5 years of engineering/quality experience in a regulated environment
- English level C1 or B2
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
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