Position SummaryWe 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.
Essential Duties and ResponsibilitiesQuality Management System (QMS)- 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.
Audits & Regulatory 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.
CAPA & Continuous Improvement- 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.
Quality Metrics & Management Review- 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.
Training & Cross-Functional Support- 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.
Required Qualifications- 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.
Preferred Qualifications- 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.
Work Environment- Office-based environment with regular interaction across Manufacturing, Engineering, Quality, and R&D teams.
- Frequent participation in audits, management reviews, and cross-functional quality activities.
- Fast-paced environment supporting multiple projects and organizational priorities.
Physical Requirements- Ability to remain in a stationary position while working at a computer for extended periods.
- Ability to occasionally move throughout office and manufacturing environments.
- Ability to communicate effectively with employees, auditors, and business partners.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position
