The main function of the Quality Systems Lead is to strengthen Supplier Quality processes through effective governance, performance management, digital solutions, and continuous improvement. This role partners across Quality, Supply Chain, Regulatory, Engineering, Operations, Sourcing, R&D, and Digital Technology to improve process execution, clarify ownership, reduce operational risk, and increase leadership visibility.
The position translates business needs and process data into practical, scalable improvements that support compliance, audit readiness, supply continuity, data integrity, and informed decision-making.
Key Responsibilities:
Lead governance and continuous improvement activities for Supplier Quality processes, including supplier notice of change (NOC), and sustainment mechanisms.
Use metrics and trend analysis to identify aging work, process barriers, ownership gaps, and areas requiring leadership attention or resource prioritization. Drive results to performance management objectives (PMOs), including those related to supplier NOC.
Translate business requirements and user feedback into practical digital solutions, workflow improvements, automation, reporting, and enhanced user experience.
Partner across functions to resolve complex issues, manage competing priorities, and drive timely, risk-based decisions without direct authority.
Develop clear recommendations, standard work, governance documentation, and scalable solutions that improve accountability while reducing administrative burden.
Additional Skills:
Experience in Supplier Quality, Quality Systems, manufacturing, or a related regulated environment.
Strong analytical, problem-solving, and continuous improvement skills.
Experience driving process, system, reporting, or workflow improvements.
Strong project leadership, communication, and stakeholder management skills.
Proven expertise in MS Office Suite.
Experience supporting digital transformation or business systems preferred.
Education and Experience:
Bachelor's degree or equivalent experience in a related field of study.
Experience with Supplier Quality, Quality Systems, or change-management in the medical device industry preferred.
8-10 years of experience required.
Numbers & Facts
Location
Santa Ana, CA
Skills
Aging Analysisunmatched
Analysis Skillsunmatched
Automationunmatched
Business Processesunmatched
Business Solutionsunmatched
Business Transformationunmatched
Continuous Improvementunmatched
Customer/Client Researchunmatched
Data Processingunmatched
Data Qualityunmatched
Documentationunmatched
Establish Prioritiesunmatched
Leadershipunmatched
Manufacturing Systemsunmatched
Medical Equipmentunmatched
Metricsunmatched
Microsoft Officeunmatched
Network Operations Centerunmatched
P-Channel Metal Oxide Semiconductor (PMOS)unmatched
Performance Managementunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Regulationsunmatched
Requirements Managementunmatched
Research & Development (R&D)unmatched
Riskunmatched
Risk Managementunmatched
Supply Chainunmatched
Time Managementunmatched
Trend Analysisunmatched
User Interface/Experience (UI/UX)unmatched
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