Quality Engineer – ISO/FDA Audits & CAPA

HW Staffing Solutions; Milford (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

HW Staffing Solutions is seeking a quality-focused engineer in Milford, MA to support a regulated manufacturing environment. You will review quality records, process nonconformances, and help drive product quality excellence.

Collaborating with cross-functional teams, you will assist investigations, CAPAs, and monitor quality metrics while supporting internal, supplier, customer, and regulatory audits to maintain ISO 9001, ISO 13485, and FDA compliance.

Qualifications

• Bachelor's degree in Engineering required.
• 1-3 years in quality, manufacturing, or engineering.
• Knowledge of QMS, RCA, and problem-solving methodologies.
• Strong analytical, organizational, and communication skills.

Responsibilities

• Review and process quality records and MRB activities.
• Support investigations, root cause analysis, and CAPAs.
• Monitor quality metrics and identify trends; collaborate on process improvements.
• Support audits and ensure ISO 9001, ISO 13485, FDA compliance.

Skills

QMS knowledge

Root cause analysis

Problem solving

Analytical thinking

Communication

Education

Bachelor's degree in Engineering

Tools

MS Office

Job description

HW Staffing Solutions is seeking a quality-focused engineer in Milford, MA to support a regulated manufacturing environment. You will review quality records, process nonconformances, and help drive product quality excellence.

Collaborating with cross-functional teams, you will assist investigations, CAPAs, and monitor quality metrics while supporting internal, supplier, customer, and regulatory audits to maintain ISO 9001, ISO 13485, and FDA compliance.