Quality Systems Manager

Glaukos Corporation; Aliso Viejo (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Glaukos Corporation is seeking a Senior QA/QMS Leader to guide the Quality Management System, ensuring regulatory compliance and continuous improvement. You will oversee CAPA, audits, and document control while partnering with cross-functional teams to drive process excellence.

The role emphasizes leadership, setting quality metrics, and coaching the quality team to achieve operational excellence in a regulated medical device environment. Onsite work in California is required.

Qualifications

• Bachelor's degree and 8+ years in QA/QMS or medical devices.
• At least 1 year of people leadership experience.
• Strong knowledge of FDA QSR, ISO 13485, and medical device quality requirements.

Responsibilities

• Lead QMS implementation, maintenance, and improvement across the organization.
• Oversee document control, CAPA, internal audits, training, and mgmt reviews.
• Drive quality initiatives with cross-functional teams for regulatory readiness.
• Manage external audits and inspections, including responses and follow-ups.
• Partner with departments to ensure effective quality processes.
• Develop and coach quality team while tracking metrics and improvements.

Skills

Quality leadership

Quality metrics analysis

FDA QSR knowledge

ISO 13485 knowledge

CAPA management

Audits management

Document control

Cross-functional leadership

Regulatory readiness

Education

Bachelor's degree in QA/Regulatory/Engineering or related field

Tools

CAPA software

Document control system

Audit management tools

Job description

How You'll Contribute

Lead and continuously improve the Quality Management System (QMS) to ensure compliance with regulatory requirements, quality standards, and company objectives while fostering a culture of quality and operational excellence.

What You'll Do

• Lead the implementation, maintenance, and continuous improvement of the QMS across the organization.
• Oversee key quality system functions, including 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.

How You'll Get There

Required Qualifications

• Bachelor's degree and 8+ years of experience in Quality Assurance, Quality Systems, or related medical device quality functions.
• Minimum 1 year of people leadership, supervisory, or management experience.
• Strong knowledge of FDA Quality System Regulation (QSR), ISO 13485, and applicable medical device quality requirements.
• Experience managing audits, CAPA programs, document control, and Quality Management System activities in a regulated environment.
• Experience leading cross-functional projects and driving quality system improvements.
• Ability to analyze quality metrics and translate findings into actionable improvements.
• Strong written, verbal, organizational, and leadership skills.
• Quality certifications (ASQ CQE, CQA, or equivalent) preferred.
• This role is based onsite …