Senior Supplier Quality Engineer – Audits, CAPA & ISO 9001

Talent Groups; Waltham (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

Talent Groups is seeking a Senior Supplier Quality Engineer to lead supplier audits, risk assessments, and ISO 9001-compliant quality activities. You will drive CAPA programs, manage SCARs/NCMRs/SCNs, and collaborate with manufacturing and quality teams to ensure robust supplier performance.

The ideal candidate has 7+ years in supplier quality or related fields, strong root-cause analysis skills, and familiarity with FDA/GMP/eQMS tools. Willingness to travel for supplier evaluations is required.

Qualifications

• Bachelor’s degree in Engineering, Quality, or a related technical field.
• 7+ years of experience in Supplier Quality Engineering, Manufacturing Engineering, or Quality Assurance.
• Experience with supplier quality management systems, process audits, and ISO 9001.
• Strong knowledge of root cause analysis, CAPA, risk assessment, and quality improvement methodologies.
• Familiarity with FDA, GMP, eQMS systems, and digital audit tools.
• Excellent communication, problem-solving, and stakeholder management skills.
• Willingness to travel for supplier audits and evaluations.
• Conduct supplier audits, qualifications, and risk assessments to ensure compliance with ISO 9001, FDA, GMP, and internal quality standards.
• Manage Supplier Corrective Action Requests (SCARs), Non-Conformance Material Reports (NCMRs), and Supplier Change Notifications (SCNs).
• Perform root cause analysis and drive effective CAPA.

Responsibilities

• Conduct supplier audits and risk assessments to ensure compliance with ISO 9001, FDA, GMP and internal standards.
• Manage SCARs, NCMRs, and SCNs.
• Lead CAPA activities and drive corrective actions.
• Perform root cause analysis and implement preventive measures.
• Collaborate with internal and external stakeholders to improve supplier quality processes.
• Support audits and training across supplier networks.

Skills

Root cause analysis

CAPA

Risk assessment

Quality improvement

Communication

Stakeholder management

Travel readiness

Education

Bachelor’s degree in Engineering, Quality, or related technical field

7+ years in Supplier Quality/Quality Assurance/Manufacturing Engineering

Job description

Talent Groups is seeking a Senior Supplier Quality Engineer to lead supplier audits, risk assessments, and ISO 9001-compliant quality activities. You will drive CAPA programs, manage SCARs/NCMRs/SCNs, and collaborate with manufacturing and quality teams to ensure robust supplier performance.

The ideal candidate has 7+ years in supplier quality or related fields, strong root-cause analysis skills, and familiarity with FDA/GMP/eQMS tools. Willingness to travel for supplier evaluations is required.