Senior Supplier Quality Engineer II

Glaukos Corporation; Burlington (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

Glaukos Corporation is seeking a Sr. Supplier Quality Engineer II to join the Global Quality team in Burlington, MA. The role focuses on ensuring supplier quality, compliance, and performance across development, manufacturing, and distribution of medical devices and pharmaceuticals.

You will lead audits, drive corrective actions, and collaborate with cross-functional teams to optimize supplier performance and product reliability. Domestic travel up to 50% is required.

Qualifications

• Bachelor’s degree in Engineering or related technical discipline required.
• 8+ years of experience in Supplier Quality/Quality Engineering or related field.
• Experience in medical device/pharma manufacturing environments.

Responsibilities

• Lead supplier qualification, assessment, and performance management activities.
• Conduct supplier audits, assessments, and on-site inspections for 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/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 QMS improvements and organizational quality initiatives.
• Travel domestically up to 50% to support supplier-related activities.

Skills

Supplier Quality

Quality Engineering

Audits

QMS

Root cause investigations

Regulatory compliance

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree in Engineering

Job description

GLAUKOS - SR. SUPPLIER QUALITY ENGINEER II

Location: Burlington, MA

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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