Quality Systems & Improvement Leader

Responsibilities

• Be the Guardian of Compliance: Ensure our site Quality Management System (QMS) stays ahead of the curve—maintaining full compliance with corporate standards, FDA regulations, ISO 13485, and industry best practices.
• Drive Performance Through Data: Monitor and analyze quality system performance using metrics, trend analysis, and internal audits.
• Lead Digital Transformation: Oversee the implementation of our site's eDHR (electronic Device History Record) program.
• Innovate & Improve: Spearhead quality system improvement initiatives by hunting down gaps, inefficiencies, and risks, then implementing smart, data-driven solutions using structured methodologies like Lean, Six Sigma, and risk-based.
• Break Down Silos: Collaborate cross-functionally with Manufacturing, Engineering, Supply Chain, IT, and Regulatory Affairs teams to ensure quality system processes are aligned and effective.
• Tell the Quality Story: Provide regular, insightful updates to leadership on quality system health, emerging risks, and improvement initiatives that matter.
• Create compelling data visualizations and dashboards that communicate trends clearly and drive meaningful action across the organization.
• Build & Develop Your Team: Supervise and mentor a team of 2+ quality associates by setting clear goals, providing hands-on coaching, and fostering a culture of accountability, collaboration, and continuous improvement that extends beyond your immediate team.
• Promote and embed a culture of quality and continuous improvement throughout the entire plant—making quality everyone's responsibility.
• Ensure Safety Compliance: Maintain full compliance with all local, state, federal, and BD Safety regulations, policies, and procedures, including RCRA Hazardous waste regulations.
• Uphold Quality Standards: Consistently apply sound quality assurance principles and comply with all local BD quality policies, procedures, and practices.

Requirements

• Requires a bachelor’s degree and a minimum of 2 years’ experience, or 6 years relevant experience.
• Preferred Qualifications: 1 year of direct supervisory experience of technical professionals, Leadership and project management experience, Medical device or pharmaceutical experience, ASQ certified quality technician (CTQ) or ASQ QE certification, Continuous Improvement experience and Six Sigma Green Belt certification/training, Process validation, Design of Experiment (DOE), 21 CFR 820-21/211 cGMP, ISO 13485-9001 experience, Experience with Minitab, SAP, and TrackWise, Knowledge of applicable regulatory requirements.