Quality Assurance Professional
We are seeking a Quality Assurance Manager to lead the quality assurance agenda across our organization.
* Ensure compliance with customer requirements and regulatory standards.
* Implement design controls to ensure product quality.
* Manage risk and regulatory affairs, including maintenance of ISO13485 and FDA requirements.
* Represent the quality department in NPI/NPD activities to ensure compliance with international quality and regulatory requirements.
* Manage change control process and ensure products are cleared to appropriate markets.
* Provide regulatory affairs support to internal and external customers.
* Maintain awareness of changing regulatory and compliance requirements.
The ideal candidate will have a university degree or postgraduate qualification in quality assurance, 8+ years of experience in medical devices or regulated industry, and significant regulatory affairs experience. Strong leadership, communication, and project management skills are essential.
Responsibilities: Lead the company-wide quality assurance agenda, ensure effective functioning of continuous quality improvement based on performance measurement.