
Senior Quality Assurance Specialist
2 days ago
A seasoned Quality Assurance Executive is sought after to oversee and implement quality procedures, ensure compliance with regulatory standards, and maintain a robust QA system.
Key Responsibilities:
- Develop and execute quality plans, ensuring adherence to ISO 13485 and FDA regulations
- Conduct regular audits, training sessions, and corrective actions to maintain the QA system's efficacy
- Manage personnel qualification, certification, and training records
- Approve or disapprove suppliers, vendors, facilities, equipment, processes, and materials according to the company's Quality Manual
Regulatory Compliance and Affairs:
- Oversee regulatory submissions in various countries, ensuring timely and accurate filings
- Provide regulatory support across company functions, including marketing and labeling
- Design and conduct tests/bench tests for regulatory compliance
- Review and approve marketing, social media, and labeling materials for regulatory adherence
Experience and Skills:
- Hands-on experience in Medical Devices with implementation of QMS and Regulatory submissions as per ISO 13485, FDA, CE, MDD, MDR, and MEDDEV
- Strong knowledge of GLP/GMP requirements for SOP drafting and maintenance
- Proven experience in internal/external audits/inspections, ensuring seamless quality management
Requirements:
- Medical Devices industry experience with a strong focus on quality management
- Implementation of QMS and Regulatory submissions with a track record of success
- In-depth knowledge of GLP/GMP principles and practices
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