Senior Medical Device QMS & Compliance Lead

Eliassen Group; Plano (TX); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k with company matching

Life insurance

Job summary

Eliassen Group seeks a Quality Systems Specialist III to lead and enhance the company’s QMS for ISO 13485, FDA, and EU MDR compliance. The role focuses on CAPA, audits, and continuous improvement, requiring collaboration across R&D, manufacturing, regulatory, and supply chain.

The ideal candidate has 5+ years in QA, strong regulatory knowledge, and proven ability to present to leadership, ensuring top-quality assurance across the organization.

Qualifications

• Minimum 5 years in Quality Assurance with 3+ years in QMS management in medical devices.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR.
• Experience auditing and leading CAPA processes.

Responsibilities

• Oversee daily QMS operations to ensure compliance with global regulations.
• Lead QMR meetings, data collection, slide preparation, and notes.
• Drive continuous improvement of the QMS and CAPA effectiveness.
• Develop and revise SOPs and controlled documents.
• Coordinate internal and external audits and regulatory inspections.
• Prepare responses and documentation for audit inquiries.
• Generate management reports on QMS health and performance.

Skills

QMS knowledge

Regulatory requirements

Cross-functional leadership

Root cause analysis

Communication

QMS software tools

Education

Bachelor of Science in Engineering/Science

CQE or CQA certification

Tools

MasterControl

Veeva

Job description

Eliassen Group seeks a Quality Systems Specialist III to lead and enhance the company’s QMS for ISO 13485, FDA, and EU MDR compliance. The role focuses on CAPA, audits, and continuous improvement, requiring collaboration across R&D, manufacturing, regulatory, and supply chain.

The ideal candidate has 5+ years in QA, strong regulatory knowledge, and proven ability to present to leadership, ensuring top-quality assurance across the organization.