Supplier Quality Engineer

Intellectt Inc; Massachusetts; On-site; USD 90,000 - 130,000; Full time

Job summary

Intellectt Inc. is seeking a Supplier Quality Engineer with 5 to 8 years of hands-on experience in the medical device industry to support supplier-facing quality activities on an UDI remediation project spanning ~600 SKUs of Class I devices.

The role focuses on managing supplier qualification, audits, CAPAs, SCARs, and root-cause analysis while ensuring compliance with ISO 13485 and FDA 21 CFR 820. Collaboration with suppliers and internal teams is essential.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5+ years of Supplier Quality experience in medical devices.
• Experience with SCAR, CAPA, NCR, FAI/PPAP, supplier audits, and root cause analysis.
• Strong knowledge of ISO 13485 and FDA 21 CFR 820.

Responsibilities

• Manage supplier qualification, audits, SCARs, NCRs, CAPAs, and supplier performance.
• Review supplier processes, inspection methods, specifications, and quality documentation.
• Support supplier PPAP/FAI, process validations, and change control activities.
• Investigate supplier-related defects and drive root cause and corrective actions.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and medical device quality systems.
• Partner with suppliers and internal teams to resolve quality issues and improve process capability.

Skills

Root cause analysis

Quality systems

Auditing

Supplier collaboration

Education

Bachelor’s degree in Engineering

Job description

Hiring a Supplier Quality Engineer with 5 to 8 years of hands‑on experience in the medical device industry. This role supports supplier‑facing quality activities as part of a UDI remediation project spanning ~600 SKUs of Class I medical devices.

Duties & Responsibilities:

• Manage supplier qualification, audits, SCARs, NCRs, CAPAs, and supplier performance.
• Review supplier processes, inspection methods, specifications, and quality documentation.
• Support supplier PPAP/FAI, process validations, and change control activities.
• Investigate supplier‑related defects and drive root cause and corrective actions.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, and medical device quality systems.
• Partner with suppliers and internal teams to resolve quality issues and improve process capability.
• Bachelor’s degree in Engineering or related field.
• 5+ years of Supplier Quality experience in medical devices.
• Experience with SCAR, CAPA, NCR, FAI/PPAP, supplier audits, and root cause analysis.
• Strong knowledge of ISO 13485 and FDA 21 CFR 820.