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Job Overview: As a Senior Quality Assurance Specialist at Exeltis, you will play a crucial role in ensuring the establishment, implementation, and maintenance of quality systems across our markets. This position requires strong regulatory knowledge, excellent communication skills, and the ability to collaborate with cross-functional teams to drive continuous improvement.
Estimated Salary: $80,000 - $110,000 per year
Responsibilities:
- Maintain accurate documentation of quality management systems, processes, and procedures.
- Analyze performance data to inform the annual management review meeting and identify areas for improvement.
- Participate in the design and implementation of quality management systems and provide ongoing support to ensure their effectiveness.
- Deploy approved quality objectives and improvements through the management review process.
- Communicate quality-related information to management and facilitate training programs to enhance staff knowledge of regulatory requirements and quality management systems.
- Record and resolve quality incidents, including internal and external audits.
- Provide technical oversight and support to quality teams in resolving complex quality issues and managing quality documentation.
- Manage third-party quality agreements, identify risks, and propose mitigation strategies.
- Collaborate on strategic quality initiatives, develop monitoring plans, and report deviations from established goals to management.
- Support the implementation of a digital quality strategy and ensure conformity checks before product release.
- Stay up-to-date with applicable regulations and promote a culture of quality excellence throughout the organization.
Requirements:
- Strong understanding of regulatory requirements, including UNE-EN ISO 13485 and GxP.
- Proven experience in quality assurance, quality management systems, or a related field.
- Excellent communication, collaboration, and problem-solving skills.
- Ability to analyze data, identify trends, and drive process improvements.
