Quality Systems & Improvement Leader
On-site · Sandy, Utah, United States
Job Summary
Lead and maintain the site's Quality Management System (QMS) with oversight of eDHR; drive data-driven quality improvements and regulatory compliance; serve as SME during audits and inspections; develop and execute corrective actions with robust root-cause analysis; collaborate across Manufacturing, Engineering, Supply Chain, IT, and Regulatory Affairs; build data visualizations and dashboards to communicate quality trends; supervise and develop a team of 2+ quality associates; ensure adherence to FDA, ISO 13485, cGMP, and BD quality policies; promote a culture of quality and continuous improvement; on-site presence required with flexible arrangements communicated per role.
Required Qualifications
- Bachelor’s degree or higher and a minimum of 2 years’ experience, or 6 years relevant experience
- 1 year of direct supervisory experience of technical professionals (preferred)
- ASQ certified quality technician (CTQ) or ASQ QE certification (preferred)
- Continuous Improvement experience and Six Sigma Green Belt certification/training (preferred)
- Process validation, DOE, 21 CFR 820-21/211 cGMP, ISO 13485-9001 experience (preferred)
- Experience with Minitab, SAP, and TrackWise (preferred)
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.