Director of Quality - Medical Device
- Location: Dallas - Fort Worth Metro
- Working situation: Onsite
The Director of Quality will play a pivotal role in leading the QA/RA team while ensuring that quality, safety, and regulatory compliance are met through company standards. 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 Director - Quality Assurance 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 Director - Quality Assurance has the following qualifications:
- Bachelor's Degree in Biology, Chemistry, Engineering, or related fields.
- 8-10 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.