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.
Required Qualifications:
Requires a bachelor's degree and a minimum of 2 years' experience, or
6 years relevant experience
Requirements
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 and Skills:
Advanced communication skills
Analytical problem solving skills, technical writing skills, automated documentation systems and root cause analysis.
Knowledge of applicable regulatory requirements
Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story tha
Benefits
Health insuranceRemote work options
Additional Information
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.
Job Description
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.
Becton Dickinson · Usa, UT