Quality Systems Lead

We Are The People Who Give Possibilities Purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Responsibilities

• Serve as the technical lead for specifically assigned Quality System processes.
• Provide day-to-day guidance to Quality Systems personnel.
• Support workload planning, prioritization, and resource coordination.
• Act as the functional escalation point for complex quality and compliance issues as needed.
• Drive consistent application and interpretation of quality procedures and regulatory requirements.
• Support departmental objectives and Quality Management System (QMS) initiatives.
• Lead projects focused on compliance improvements, process optimization, and business effectiveness.
• Provide oversight and guidance for one or more of the Quality System processes as business needs deem necessary.
• Facilitate escalation of systemic product or process issues impacting the Quality System.
• Support CAPA activities including initiation, investigation, root cause analysis, action development, implementation, and effectiveness verification.
• Support audit planning, execution, reporting, and follow-up activities.
• Facilitate corrective actions resulting from audits and inspections.
• Support management review activities and quality governance forums.
• Prepare quality system metrics, dashboards, and performance reports.
• Ensure compliance with applicable regulations, standards, and company procedures.
• Participate in regulatory inspections and customer audits.
• Support responses to audit observations and compliance commitments.
• Support in the development and analysis of Quality System performance metrics.
• Support in the monitoring process effectiveness and identify opportunities for improvement.
• Conduct trend analysis to identify emerging compliance risks.
• Utilize data to drive risk-based decision-making and continuous improvement initiatives.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Business Administration, or a related discipline (preferred).
• Minimum 5-8 years of experience in Quality Systems, Quality Assurance, Quality Compliance, or regulated industry environments (preferred).
• Experience in multiple Quality System processes preferred.
• Experience supporting regulatory inspections and audits.

Skills

• Advanced knowledge of Quality Management Systems and applicable regulations.
• Strong understanding of CAPA, Change Control, Training, Audit, Complaints, and Document Control