Quality Systems Lead for MedTech Compliance & Improvement

Becton Dickinson NA; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

BD in Covington, GA is seeking a Quality Specialist to support laboratory operations with quality expertise across medical product testing activities. You will ensure processes meet corporate quality standards and regulatory requirements while driving continuous improvement.

The role requires a Bachelor's degree in a lab-related field and 2 years of regulated-lab experience, with on-site work expectations and emphasis on ISO 13485, ISO 17025, and 21 CFR 820 compliance.

Qualifications

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

Responsibilities

• Coordinate and maintain a robust, standardized laboratory Quality System aligned with regulatory requirements.
• Serve as the local SME for Quality Systems, ensuring compliance and providing guidance across the organization.
• Ensure laboratory processes, procedures, and organizational practices meet business needs and regulatory expectations.
• Promote a culture of quality and compliance, increasing awareness of ISO, QSR and related regulations.
• Lead implementation and execution of Quality System processes to achieve performance and compliance 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, ensuring actions are completed and quality initiatives progress effectively.
• Utilize metrics and performance reporting to monitor effectiveness, identify improvement opportunities, and deliver business value.
• Drive continuous improvement initiatives through lessons learned and proactive problem prevention strategies.
• Support the development and maintenance of an effective local quality organization through training and knowledge sharing.
• Oversee and support training programs, GMP/GDP compliance, LIMS operations, QMS audits, and nonconformities.
• Assist with CAPAs, validations, calibrations, and OOS investigations.

Skills

Analytical skills

Project leadership

Interpersonal skills

Communication

Education

Bachelor's degree in laboratory science

Tools

Excel

Word

PowerPoint

Job description

BD in Covington, GA is seeking a Quality Specialist to support laboratory operations with quality expertise across medical product testing activities. You will ensure processes meet corporate quality standards and regulatory requirements while driving continuous improvement.

The role requires a Bachelor's degree in a lab-related field and 2 years of regulated-lab experience, with on-site work expectations and emphasis on ISO 13485, ISO 17025, and 21 CFR 820 compliance.