Staff Quality Auditor - Remote

Overview

The Staff Quality Auditor is responsible for implementing and overseeing the BD Quality Audit program, ensuring compliance with quality and regulatory standards across BD facilities.

In Short

• Implement and oversee quality audit programs.
• Conduct quality and regulatory audits of BD facilities.
• Provide training and guidance for quality auditors.
• Monitor completion of corrective action plans.
• Coordinate reporting of compliance metrics.
• Assist with continuous improvement projects.
• Function as a subject matter expert for quality and compliance issues.
• Travel domestically and internationally (25-50%).
• Maintain audit system software database.
• Prepare periodic reports on audit statuses.

Requirements

• B.S. in Engineering, Chemistry, Biology or equivalent, advanced degree preferred.
• 10 years of experience in Quality within Medical Device or pharmaceutical companies.
• 5+ years of auditing experience with compliance regulations.
• Knowledge of FDA QSR, ISO 13485, MDSAP, and EU MDR/IVDR standards.
• Excellent communication and analytical skills.
• Ability to collaborate effectively with management.
• Strong project management and organizational skills.
• Certifications in Quality Auditing preferred.
• Demonstrated knowledge in CAPA and Root Cause Investigation.
• Ability to handle time and resources effectively.

Benefits

• Competitive salary range of $130,400 - $215,200 annually.
• Opportunities for professional development and training.
• Supportive work environment that values contributions.
• Flexible work-life balance arrangements.
• Commitment to diversity and equal opportunity.