Quality Systems & Improvement Leader

Job Description

Required Skills

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.
• Be the Expert Voice: Serve as the go-to subject matter expert (SME) during internal and external audits and regulatory inspections
• Turn Findings into Wins: Lead and support remediation activities from audits, inspections, or compliance gaps. You'll develop and execute corrective action plans with thorough root cause analysis that prevents recurrence.
• 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.
• Make Data Visual: 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.
• Be a Culture Champion: 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.
• Requires a bachelor's degree and a minimum of 2 years' experience, or
• 6 years relevant experience
• 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