Quality Assurance Lead

Drive Medical•Palmetto, GA

1d•Onsite

About The Position

The Quality Assurance Lead will be responsible for promoting a culture of quality and continuous improvement throughout the organization. This role will be responsible for leading the Quality Management System including regular, cross-functional reporting mechanisms such as QRC, CRB, MRB and others. This role will report to the Senior Director, Quality Assurance. This position is on-site, and will sit inside a Distribution Center Warehouse facility.

Requirements

Bachelor's degree in Life Science, Bioengineering or similar with 3-5 years of experience working in a manufacturing environment.
Understanding of product development, manufacturing, quality and servicing in the medical device or pharmaceutical industry.
Team mindset
Excellent communication abilities
Strong analytical skills
Critical thinker
Creative problem-solving capabilities
Detailed-oriented and able to perform in high-pressure environment.

Nice To Haves

Experience with medical devices preferred.

Responsibilities

Promote a culture of quality and continuous improvement throughout the organization.
Lead the Quality Management System including regular, cross-functional reporting mechanisms such as QRC, CRB, MRB and others.
Establish and evolve quality metrics monitoring, trending, response, and promotion to corrective actions as appropriate.
Develop, implement, and improve SOP for continued compliance and product iterations.
Review documentation to ensure appropriate risk assessment, action plan, and effectiveness of implementations.
Ensure site readiness for external audits and inspections.
Support and participate in external audits and inspections as appropriate.
Review training curricula for applicability, completeness, and strength of program.
Perform tasks in accordance with GMP and other applicable regulations, standards, and requirements.