Quality Systems & Improvement Leader

Becton Dickinson Medical Devices • Sandy, UT

12h • Onsite

About The Position

The Quality Systems & Improvement Leader is responsible for ensuring the effectiveness, compliance, and continuous improvement of the site Quality Management System (QMS). This role provides leadership and oversight of quality system processes, including electronic Device History Records (eDHR), and drives initiatives to enhance quality, compliance, and operational efficiency.

Requirements

• Requires a bachelor’s degree and a minimum of 2 years’ experience, or 6 years relevant experience

Nice To Haves

• 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.
• Advanced communication skills
• Analytical problem solving skills, technical writing skills, automated documentation systems and root cause analysis.
• Knowledge of applicable regulatory requirements

Responsibilities

• Ensure the site Quality Management System (QMS) stays ahead of the curve—maintaining full compliance with corporate standards, FDA regulations, ISO 13485, and industry best practices
• Monitor and analyze quality system performance using metrics, trend analysis, and internal audits.
• Oversee the implementation of the site's eDHR (electronic Device History Record) program
• 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.
• Serve as the go-to subject matter expert (SME) during internal and external audits and regulatory inspections
• Lead and support remediation activities from audits, inspections, or compliance gaps. Develop and execute corrective action plans with thorough root cause analysis that prevents recurrence.
• Collaborate cross-functionally with Manufacturing, Engineering, Supply Chain, IT, and Regulatory Affairs teams to ensure quality system processes are aligned and effective.
• 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.
• 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.
• Maintain full compliance with all local, state, federal, and BD Safety regulations, policies, and procedures, including RCRA Hazardous waste regulations.
• Consistently apply sound quality assurance principles and comply with all local BD quality policies, procedures, and practices.

Benefits

• We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture.
• Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level