Supplier Quality Engineer

Shoolin Inc; Town of Florida (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Shoolin Inc in New York is seeking a Supplier Quality Engineer with strong Medical Device industry experience to support supplier quality, quality systems, and supplier improvement activities. The role requires 2+ years of supplier quality engineering, expertise in ISO 13485 and FDA 21 CFR 820, and hands-on experience with supplier audits, CAPA, NCR, SCAR, and root cause analysis.

You will work with suppliers and cross-functional teams to drive corrective actions and support NPI, process

Qualifications

• 2+ years of supplier quality engineering experience.
• Medical Device industry experience.
• Knowledge of ISO 13485 and FDA 21 CFR 820.
• Experience with supplier audits, CAPA, NCR, SCAR, and root cause analysis.
• Experience with supplier qualification and performance monitoring.
• Knowledge of NPI, process validation, and change control.

Responsibilities

• Manage supplier quality issues, NCRs, SCARs, and CAPAs.
• Conduct supplier audits and support supplier qualification.
• Monitor supplier performance and drive corrective actions.
• Support NPI, validation, and engineering change activities.
• Work with suppliers and cross-functional teams to resolve quality issues.

Skills

Supplier quality

CAPA/NCR/SCAR

Root cause analysis

Supplier audits

NPI & validation

Change control

Quality systems

Education

Bachelor’s degree in Engineering or related field

Job description

Seeking a Supplier Quality Engineer with strong Medical Device industry experience to support supplier quality, quality systems, and supplier improvement activities.

Required Experience:

• 2+ years of Supplier Quality Engineering experience
• Medical Device industry experience
• Strong knowledge of ISO 13485 and FDA 21 CFR 820
• Experience with supplier audits, CAPA, NCR, SCAR, and root cause analysis
• Experience with supplier qualification and performance monitoring
• Knowledge of NPI, process validation, and change control
• Bachelor’s degree in Engineering or related field

Key Responsibilities:

• Manage supplier quality issues, NCRs, SCARs, and CAPAs.
• Conduct supplier audits and support supplier qualification.
• Monitor supplier performance and drive corrective actions.
• Support NPI, validation, and engineering change activities.
• Work with suppliers and cross-functional teams to resolve quality issues.