Sr. Supplier Quality Engineer II

Glaukos Corporation; San Clemente (CA); Presencial; USD 110.000 - 150.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Supplier quality

Auditing

Root cause analysis

Regulatory knowledge

Communication

Educación

Bachelor's degree in Engineering or related

Descripción del empleo

GLAUKOS - SR. SUPPLIER QUALITY ENGINEER II

Location: Aliso Viejo, CA

How will you make an impact?

As a key member of the Global Quality team, you will help ensure the quality, compliance, and performance of suppliers supporting the development, manufacture, and distribution of innovative medical devices and pharmaceutical products. You will partner with cross-functional teams and suppliers to drive quality excellence, continuous improvement, and supplier performance across the product lifecycle.

What will you do?

• Lead supplier qualification, assessment, and performance management activities.


• 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.

How will you get here?

• Bachelor's degree in Engineering or related technical discipline.


• 8+ years of experience in Supplier Quality, Quality Engineering, or a related field.


• Experience within medical device and/or pharmaceutical manufacturing environments.


• Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and applicable quality system requirements.


• Experience conducting supplier audits and managing supplier quality programs.


• Knowledge of QMS, root cause investigations, corrective actions, and supplier performance management.


• ASQ certifications such as CQE, CQA, CBA, or CSSBB are preferred.


• Strong communication, collaboration, problem-solving, and organizational skills.

Why Join Us?

At Glaukos, you'll have the opportunity to work with innovative technologies that help improve patient outcomes around the world. You'll collaborate with talented colleagues, influence supplier quality strategy, and play a meaningful role in supporting the delivery of high-quality products to patients and providers.

This position is based in Aliso Viejo, California, with travel to supplier sites as needed.

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