Quality Systems Lead - MedTech Lab Compliance and CAPA

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

Job summary

BD is seeking a Quality Specialist to support laboratory operations and ensure all testing activities meet regulatory standards and corporate quality requirements. You will drive continuous improvement, manage document control, and lead quality initiatives in a regulated lab environment.

The role emphasizes QA governance, CAPA activities, and cross‑functional collaboration to uphold ISO 13485, ISO 17025, and 21 CFR 820 requirements at a BD site in the USA Georgia region.

Qualifications

• Bachelor’s degree in laboratory related science (Chemistry, Microbiology or related field).
• 2 years of experience in a laboratory in a regulated industry.

Responsibilities

• Coordinate and maintain a robust laboratory Quality System aligned with regulatory requirements.
• Serve as the local SME for Quality Systems, ensuring compliance.
• Ensure laboratory processes, procedures, and practices meet business needs and regulatory expectations.
• Promote a culture of quality and compliance with ISO, QSR and related regulations.
• Lead implementation and execution of Quality System processes to meet objectives.
• Support and maintain document control and record management processes.
• Lead local implementation of annual Quality Objectives and Key Business Drivers for laboratory operations.
• Participate in and facilitate Quality Leadership meetings and track actions.
• Use metrics to monitor effectiveness and identify improvement opportunities.
• Drive continuous improvement through lessons learned and best practices.
• Support development of local quality organization through training and mentoring.
• Oversee training programs, GMP/GDP compliance, LIMS operations and QMS audits.
• Assist with CAPAs, validations, calibrations, and OOS investigations.
• Plan and participate in internal/external audits and ensure compliance with regulations.

Skills

Excel

Analytical thinking

Project leadership

Communication

Process improvement

Education

Bachelor’s degree in laboratory science

Tools

LIMS

Job description

BD is seeking a Quality Specialist to support laboratory operations and ensure all testing activities meet regulatory standards and corporate quality requirements. You will drive continuous improvement, manage document control, and lead quality initiatives in a regulated lab environment.

The role emphasizes QA governance, CAPA activities, and cross‑functional collaboration to uphold ISO 13485, ISO 17025, and 21 CFR 820 requirements at a BD site in the USA Georgia region.