
Quality Assurance Specialist
23 hours ago
Job Title:
Medical Device Quality Assurance ManagerWe are seeking an experienced Medical Device Quality Assurance Manager to oversee our regulatory compliance and ensure the quality of our medical devices.
Responsibilities:
- Develop and implement quality management systems (QMS) to ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Coordinate with regulatory authorities for obtaining required permissions and approvals.
- Manage risk assessment, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and Class III medical devices.
- Oversee regulatory submissions and ensure timely approvals.
- Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
Requirements:
- Strong understanding of quality systems and regulatory frameworks for medical devices.
- Hands-on experience with regulatory submissions, PMS, and risk management.
- Excellent knowledge of GMP, GDP, and ISO 13485 standards.
- Strong communication, documentation, and coordination skills.
We offer a competitive salary and benefits package in exchange for your expertise and dedication.
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