Senior Quality Systems Specialist

THE ALFRED E MANN FOUNDATION FOR SCIENTIFIC R•Santa Clarita, CA

3d•$94,000 - $105,000•Onsite

About The Position

We are seeking an experienced Senior Quality Systems Specialist to support and continuously improve our Quality Management System (QMS) while ensuring compliance with ISO 13485:2016, applicable regulatory requirements, and company quality objectives. This role serves as a Quality Systems Subject Matter Expert (SME), partnering with Research & Development, Manufacturing, Quality Assurance, and cross-functional teams to promote a culture of quality and compliance throughout the organization. The ideal candidate is highly organized, detail-oriented, and passionate about building effective quality systems that support operational excellence, audit readiness, and continuous improvement.

Requirements

Bachelor's degree or equivalent combination of education and experience.
Minimum of 10 years of combined practical and educational experience within the medical device industry.
Hands-on experience maintaining and improving Quality Management Systems.
Strong working knowledge of ISO 13485:2016 requirements.
Excellent technical writing, documentation, and communication skills.
Experience developing and maintaining SOPs, work instructions, forms, and controlled documents.
Experience planning, conducting, and supporting internal and external audits.
Strong analytical, organizational, and problem-solving skills.
Advanced proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Visio, and database systems.
Ability to manage multiple priorities and work independently.
Ability to quickly understand complex processes and quality system requirements.

Nice To Haves

Experience serving as a Quality Systems SME in a medical device environment.
Experience leading ISO certification, surveillance, and regulatory audits.
Working knowledge of FDA Quality System Regulations (QSR/QMSR).
Experience supporting CAPA, nonconformance, and quality improvement programs.
Experience developing quality metrics, dashboards, and management review presentations.
Experience leading cross-functional quality system improvement initiatives.
Strong understanding of risk-based quality management principles.

Responsibilities

Develop, implement, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, regulatory requirements, and company procedures.
Serve as the Quality Systems Subject Matter Expert (SME) and provide guidance on quality system requirements and best practices.
Develop, revise, and maintain SOPs, work instructions, forms, templates, and other controlled documents.
Review and approve quality system documentation to ensure consistency, accuracy, and compliance.
Plan, schedule, coordinate, and conduct the internal audit program.
Prepare audit reports, communicate findings, and support follow-up activities.
Serve as the primary coordinator and host for external audits, including ISO certification and surveillance audits.
Support organizational audit readiness by preparing documentation and coordinating cross-functional activities.
Track audit observations and nonconformances through closure and effectiveness verification.
Support the CAPA program by facilitating investigations, root cause analysis, corrective actions, and effectiveness checks.
Collaborate with cross-functional teams to resolve quality system issues and improve compliance.
Lead QMS improvement projects and process optimization initiatives.
Identify opportunities to improve efficiency, effectiveness, and overall quality system performance.
Develop, monitor, analyze, and report Quality Objectives, KPIs, and quality system metrics.
Create dashboards, trend analyses, and reports to support decision-making and continuous improvement activities.
Lead preparation of Management Review materials by collecting and analyzing quality system data.
Present trends, metrics, and recommendations that support executive review and business objectives.
Provide guidance, coaching, and training on quality system requirements, processes, and procedures.
Partner with Manufacturing, Engineering, Quality Assurance, and R&D teams to promote compliance and process consistency.
Support company-wide initiatives that strengthen quality culture and operational excellence.
Act as a resource for interpreting quality system requirements and regulatory expectations.