Quality Assurance - Medical Device
- Location: Miami-Fort Lauderdale Area
- Working situation: Hybrid
Role Overview:
The Quality Manager will play a pivotal role in leading the Quality team while ensuring that quality, safety, and regulatory compliance are met. You will foster a culture of quality and compliance through strong leadership while also ensuring that all products are in compliance with the applicable regulations.
The Quality Assurance Manager will:
- Manage the implementation/maintenance/continuous improvement of Quality Systems.
- Executing and implementing enhancements to existing quality system process in a manner that effectively supports the growth of the business.
- Identify, direct, and monitor activities to ensure compliance with FDA, ISO 13485 and other global regulations.
- Manage and mentor Quality management staff to promote personnel development and succession planning.
- Lead/coordinate investigations, and the development and implementation of corrective and preventative action (CAPA).
The Quality Assurance Manager has the following qualifications:
- Bachelor's Degree in Biology, Chemistry, Engineering, or related fields.
- 10 years of Quality experience in the Medical Device industry, with a minimum of 5 years in a leadership position.
- Strong understanding of FDA regulations and ISO quality standards (ISO 13485) is essential.
- Strong leadership experience not limited to mentoring, project management, and training of QA related personnel.
