Lead Quality Excellence Specialist
hace 6 horas
This highly influential position at Nextern will see you expertly managing quality requirements between the company and key customers. Your primary responsibility will be to ensure customer quality expectations are met, as well as daily requirements in engineering, production development, and supply chain. You will strike a delicate balance between these areas to achieve product quality performance that meets both company requirements and regulatory agencies' guidelines.
As part of this role, you will have supervisory responsibilities for technical and professional teams. You will develop strategies and provide mentorship on complex technical issues to your direct reports. Key tasks include:
- Leading complaint and CAPA investigations
- Communicating directly with external and internal clients
- Conducting internal audits
- Leading changes to QMS documents
- Leading multidisciplinary groups on high-complexity projects
- Validating systems, performing TMVs
- Executing IIR and FAIR reports independently
- Supporting other engineering areas with minimal or no support required
- Participating in quality leadership for development projects and performing NPI activities
Key qualifications for this role include:
- Bachelor's degree in engineering or a life science-related field, with a postgraduate degree being desirable
- 6-8 years of experience in engineering or quality within a highly regulated manufacturing/industry environment
- Vast experience in sustaining lines and supervisory roles
- English proficiency level C1
- Demonstrated ability to build collaborative relationships, drive operational excellence, and make agile decisions, with high competency in people development
The estimated annual salary for this position is around $85,000 - $110,000 based on industry standards and location factors. This competitive compensation package comes with an optimal working environment.
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