Quality Systems Leader - Medical Devices, QSR/ISO

Glaukos Corporation; Burlington (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Glaukos Corporation is seeking a Senior Quality Assurance professional to lead the QMS program onsite in the United States. You will oversee CAPA, document control, internal audits, and management reviews, while driving cross-functional quality improvements and regulatory readiness.

The role requires a strong foundation in FDA QSR, ISO 13485, and medical device quality requirements, plus leadership experience.

Qualifications

• Bachelor's degree in a relevant field with 8+ years in Quality Assurance/Quality Systems or related medical device quality functions.
• Minimum 1 year of people leadership, supervisory, or management experience.

Responsibilities

• Lead the implementation, maintenance, and continuous improvement of the QMS across the organization.
• Oversee document control, CAPA, internal audits, training, and management reviews.
• Drive quality and compliance initiatives by partnering with cross-functional teams to improve processes and regulatory readiness.
• Manage external audits and inspections, including preparation, execution, responses, and follow-up activities.
• Partner with cross-functional departments to drive quality system effectiveness and ensure consistent execution of quality processes and procedures.
• Develop, coach, and support quality team members while monitoring quality system performance metrics and continuous improvement efforts.

Skills

Quality Assurance

Quality Systems

QSR & ISO 13485

CAPA

Document Control

Audits & Inspections

Leadership

Cross-functional Collaboration

Quality Metrics & Improvements

Education

Bachelor's degree

Job description

Glaukos Corporation is seeking a Senior Quality Assurance professional to lead the QMS program onsite in the United States. You will oversee CAPA, document control, internal audits, and management reviews, while driving cross-functional quality improvements and regulatory readiness.

The role requires a strong foundation in FDA QSR, ISO 13485, and medical device quality requirements, plus leadership experience.