Quality Systems Specialist - ISO 13485 & CFR Audits

BD; Covington (VA); On-site; USD 60,000 - 85,000; Full time

Job summary

BD is seeking a Quality Specialist I to oversee and enhance quality systems within a regulated environment. The role focuses on nonconforming product disposition, audits, and continuous improvement, with responsibilities as a SME for ISO 13485 and CFR 820, including ensuring local wholesale drug license compliance.

Ideal candidates have an Associate degree (or equivalent experience), 2+ years in regulated settings, and proficiency with SAP/WMS/ERP. Travel up to 25% is expected.

Qualifications

• Associate degree, or combination of equivalent education and experience, required in lieu of a bachelor's degree.
• Minimum of 2 years of experience in a regulated environment, with a demonstrated track record of quality system management.
• Industry-recognized certification in a Quality System Element or specialty is highly desirable.
• Advanced proficiency with SAP, WMS, and other ERP platforms is required.
• Experience with Boards of Pharmacy and regulatory audits required.

Responsibilities

• Lead the evaluation and disposition of held or nonconforming products with a focus on minimizing Zero Escape incidents.
• Oversee intracompany claims and drive the resolution process.
• Conduct and manage QMS Audits, ensuring rigorous compliance and continuous improvement.
• Analyze metric data to identify trends and implement strategic quality improvements.
• Provide advanced operations support and maintain the DR License with utmost diligence.
• Act as the primary SME for ISO 13485, 21 CFR 820, and Corporate Policies/Procedures, ensuring strict adherence and application.
• Ensure the site’s compliance with local wholesale drug licenses as the designated representative.
• Mentor and train team members on QMS requirements and facilitate continuous process improvement initiatives.
• Maintain a high level of proficiency with SAP, WMS, and other ERP platforms, providing expert guidance and support.
• Assume responsibility for other positions during times of urgency, breaks, absences, or vacation to maintain operational continuity.
• Expected travel can be up to 25% of the time.

Skills

Leadership

Analytical thinking

Problem solving

Technical writing

Communication

Education

Associate degree

ASQ Certified Quality Auditor

Tools

SAP

WMS

ERP

Job description

BD is seeking a Quality Specialist I to oversee and enhance quality systems within a regulated environment. The role focuses on nonconforming product disposition, audits, and continuous improvement, with responsibilities as a SME for ISO 13485 and CFR 820, including ensuring local wholesale drug license compliance.

Ideal candidates have an Associate degree (or equivalent experience), 2+ years in regulated settings, and proficiency with SAP/WMS/ERP. Travel up to 25% is expected.