Sustaining Engineer - Supplier Quality

Qualifications

• Bachelor’s degree in engineering or related field
• Minimum of 3 years of experience in a related role within a medical device or manufacturing environment
• Experience with root cause analysis and process validation (IQ, OQ, PQ)
• Strong understanding of supplier quality management and experience supporting supplier development and qualification
• Experience working in FDA-regulated environments and managing supplier capacity ramp-up
• Familiarity with statistical analysis, process monitoring, and implementing corrective actions
• Knowledge of design, process, or quality improvements in medical devices

Responsibilities

• Lead and support continuous improvement initiatives for products, processes, and suppliers, including change control execution.
• Perform root cause analysis and implement corrective actions for component failures and non-conformances, collaborating with suppliers and internal teams.
• Support supplier qualification, capacity scaling, and validation planning to meet production demand.
• Collaborate with Quality, Manufacturing, and Product Development to define inspection requirements, verify changes, and improve next-generation products.
• Manage internal and external communication related to sustaining projects and ensure compliance with FDA and QMS documentation standards.