Quality Systems Lead — MedTech Lab Compliance

BD Mexico; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

BD is a leading medical technology company based in the United States. The Quality Specialist supports laboratory operations by applying quality expertise across medical product testing activities, from request through report generation and archiving.

In this role, you will serve as the local SME for Quality Systems, drive CAPA and continuous improvement initiatives, and ensure compliance with ISO 13485, ISO 17025 and 21 CFR 820. This on-site position is based in Covington, GA, USA.

Qualifications

• Bachelor’s degree in laboratory related science (Chemistry, Microbiology or related field).
• 2 years of experience in a laboratory in a regulated industry.
• Knowledge of ISO 13485, ISO 17025, 21 CFR 820; ASQ certification is a plus.

Responsibilities

• Maintain a robust Quality System aligned with regulatory requirements.
• Serve as local SME for Quality Systems and ensure compliance.
• Lead CAPAs, validations, calibrations, and OOS investigations.
• Support document control, audits, and QMS improvements.
• Promote quality culture and continuous improvement.

Skills

Excel

Analytical

Process improvement

Project leadership

Communication

Education

Bachelor’s degree in laboratory related science

Tools

LIMS

Job description

BD is a leading medical technology company based in the United States. The Quality Specialist supports laboratory operations by applying quality expertise across medical product testing activities, from request through report generation and archiving.

In this role, you will serve as the local SME for Quality Systems, drive CAPA and continuous improvement initiatives, and ensure compliance with ISO 13485, ISO 17025 and 21 CFR 820. This on-site position is based in Covington, GA, USA.