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Quality Assurance Specialist
2 maanden geleden
We are seeking a highly skilled and experienced Quality Assurance Specialist to join our team as a CAPA Process Facilitator. In this role, you will play a critical part in ensuring the quality and integrity of our products and processes.
Key Responsibilities- Support the CAPA process from issue identification to closure, ensuring proper execution and quality of CAPA record content.
- Review and analyze complex investigations and corrective actions to identify root causes and implement effective solutions.
- Lead root cause analysis and quality problem-solving efforts to drive continuous improvement.
- Facilitate product and process CAPA investigations from issue identification through solution implementation and effectiveness monitoring.
- Collaborate with cross-functional teams to ensure seamless execution of CAPA activities.
- Bachelor's degree in Engineering or a relevant field (e.g., statistics, quality management).
- Experience in quality roles within the medical device or other regulated industries.
- Working knowledge of global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971.
- Proficiency in statistical methods, quality tools, and problem-solving methodologies (e.g., 8D, DMAIC, SPC, FMEA, Control Plan, LEAN).
- Strong communication and interpersonal skills with the ability to coach cross-functional teams in a matrix environment.
- Strong technical writing skills and ability to resolve complex issues creatively.
We are a global leader in health technology, committed to improving billions of lives worldwide and making the world healthier and more sustainable through innovation. We are driven by a sense of purpose and determination to meet our customers' needs.
