Sr. Supplier Quality Engineer II - Medical Device QA Lead

Glaukos Corporation; San Clemente (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Glaukos Corporation, based in Aliso Viejo, California, seeks a Sr. Supplier Quality Engineer II to lead supplier qualification, audits, and performance management across the product lifecycle.

You will partner with cross-functional teams to ensure regulatory compliance and supplier quality excellence. The role requires a Bachelor's degree in Engineering and 8+ years in supplier quality or quality engineering within medical device/pharma environments, with knowledge of FDA, ISO standards, and

Qualifications

• Bachelor's degree in Engineering or related discipline.
• 8+ years of experience in Supplier Quality or Quality Engineering.
• Experience in medical device/pharma manufacturing environments.
• Knowledge of FDA regulations, ISO 13485, ISO 14971, and applicable quality system requirements.
• Experience conducting supplier audits and managing supplier quality programs.
• ASQ CQE/CQA/CBA/CSSBB preferred.
• Strong communication and problem-solving skills.

Responsibilities

• Lead supplier qualification, assessment, and performance management.
• Conduct supplier audits, assessments, and on-site inspections to ensure compliance with regulatory and company requirements.
• Drive supplier corrective actions and continuous improvement initiatives.
• Partner with Operations, Manufacturing, R&D, Regulatory Affairs, and Quality teams to support product quality and reliability.
• Review supplier risk classifications and qualification requirements for new and existing suppliers.
• Develop and maintain quality agreements and supplier quality documentation.
• Analyze supplier performance metrics and implement actions to improve quality and on-time delivery.
• Support Quality Management System (QMS) improvements and organizational quality initiatives.
• Travel domestically up to 50% to support supplier-related activities.

Skills

Supplier quality

Auditing

Root cause analysis

Regulatory knowledge

Communication

Education

Bachelor's degree in Engineering or related

Job description

Glaukos Corporation, based in Aliso Viejo, California, seeks a Sr. Supplier Quality Engineer II to lead supplier qualification, audits, and performance management across the product lifecycle.

You will partner with cross-functional teams to ensure regulatory compliance and supplier quality excellence. The role requires a Bachelor's degree in Engineering and 8+ years in supplier quality or quality engineering within medical device/pharma environments, with knowledge of FDA, ISO standards, and