Quality Engineer III — Process Improvement & Audit Lead

SGS Consulting; Boston (MA); On-site; USD 120,000 - 150,000; Full time

Job summary

SGS Consulting seeks a seasoned quality professional to drive process and product characterization for continuous improvement in a manufacturing setting. You will handle NC reports, CAPAs, and supplier-related issues while performing audits to ISO-13485 and FDA standards.

Strong data analysis and risk mitigation experience are essential. Minimum 8+ years in manufacturing/quality, with degrees ranging from Bachelor's to Doctorate as noted.

Qualifications

• Experience in manufacturing/operations required.
• FDA and ISO risk management knowledge required.
• Certified Internal Auditor to ISO-13485.

Responsibilities

• Support quality improvement initiatives for process and product characterization.
• Work on non-conforming (NC) reports and CAPA review and close.
• Conduct internal and supplier audits per ISO standards.
• Analyze data and perform statistical analyses for improvements.
• Escalate quality issues and own material identification and defect classification.

Skills

Risk management

ISO-13485 Internal Audit

Manufacturing/Operations

Statistical analysis

Education

Bachelor's degree +8+ years

Master’s degree +5+ years

Doctoral degree +3+ years

Job description

SGS Consulting seeks a seasoned quality professional to drive process and product characterization for continuous improvement in a manufacturing setting. You will handle NC reports, CAPAs, and supplier-related issues while performing audits to ISO-13485 and FDA standards.

Strong data analysis and risk mitigation experience are essential. Minimum 8+ years in manufacturing/quality, with degrees ranging from Bachelor's to Doctorate as noted.