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Senior Quality Assurance Specialist
hace 2 meses
Job Summary:
We are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at Corza Medical. As a key member of our quality team, you will be responsible for the development, implementation, and maintenance of our Veeva System, ensuring compliance with medical devices regulations and standards.
Key Responsibilities:
- Develop and implement strategies for maintaining CAPA and Audit Quality Programs aligned with medical devices regulations and company goals.
- Primary responsibility for maintaining activities related to CAPA and Audit Quality Programs, including training, access management, and quality metrics.
- Participate in projects related to Veeva updates of CAPA and Audit Modules, ensuring seamless integration and minimal disruption to business operations.
- Establish and maintain an Internal Lead Auditor Certification program, ensuring our team is equipped to conduct thorough and effective audits.
- Contribute to organizational change initiatives, fostering a culture of continuous improvement and excellence.
- Monitor and maintain CAPA activities and programs, ensuring compliance with regulatory requirements.
- Support CAPA investigations, mentoring and training team members as needed.
- Communicate effectively across teams, explaining methodology, process, and results from analysis.
- Evaluate accuracy and conformance to required procedures and performance improvement projects and initiatives.
- Prepare quality documentation, metrics, and reports, collecting, analyzing, and summarizing information and trends.
- Schedule Management Review Meetings, preparing presentations and supporting materials.
Requirements:
- Bachelor's Degree in a science, technical discipline, or equivalent experience.
- At least 5-10 years of QMS and leadership experience in medical devices.
- Bilingual, with strong verbal and written communication skills.
- Demonstrated experience working with diverse cultures, strong organizational skills, and effective communication.
- Management skills, trainer skills, and ability to establish and maintain effective interpersonal relationships.
- Experience with GMP, GDP, QMS, Audits, etc., as part of a Quality Culture.
About Corza Medical:
We foster a work environment where all team members are empowered and encouraged to share their opinions and ideas. We encourage robust, fact-based debate, and our highly collaborative work environment results in the best decisions for Corza Medical and a shared mission to execute our plan together, on time and on budget.
