Quality Engineer - FDA Remediation, CAPA & RCA

Fusion Life Sciences technologies LLC; Marlborough (MA); On-site; USD 55,000 - 62,000; Full time

Job summary

Fusion Life Sciences Technologies LLC seeks a Quality Engineer for a 6-month contract in Marlborough, MA. You will own deviations, perform RCA, and drive CAPA through closure while collaborating across Manufacturing, Quality, Engineering, Validation, and Operations.

The role requires 5+ years in the medical-device space with strong knowledge of FDA requirements and QMS. Hands-on problem-solving, documentation, and cross-functional teamwork are essential as you support remediation efforts.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing Engineering, Mechanical Engineering, or a related technical field.
• 5+ years of experience in the medical-device industry with FDA remediation exposure.
• Hands-on RCA, deviation investigations, CAPA, NCRs, change control, risk assessment, and process improvement.
• Strong knowledge of FDA medical-device requirements and QMS.
• Experience collaborating with cross-functional Manufacturing, Quality, Engineering, and Operations teams.
• Solid documentation and problem-solving skills for investigating complex issues.

Responsibilities

• Support FDA remediation activities related to manufacturing and quality processes.
• Investigate manufacturing deviations, nonconformances, and quality issues.
• Perform detailed root cause analysis and identify systemic causes.
• Develop, implement, and track CAPA activities through closure.
• Partner with Manufacturing, Quality, Engineering, Validation, and Operations teams to implement corrective actions.
• Support process improvements, process validation, equipment qualification, and manufacturing-readiness activities.
• Review and update manufacturing procedures, work instructions, specifications, and technical documentation.
• Analyze quality and manufacturing data to identify trends, recurring issues, and risks.
• Support audit and regulatory inspection readiness.

Skills

Root cause analysis

CAPA

Deviation investigations

Change control

Risk assessment

Process improvement

Quality systems (FDA 21 CFR Part 820)

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering or related field

Tools

FDA remediation

Job description

Fusion Life Sciences Technologies LLC seeks a Quality Engineer for a 6-month contract in Marlborough, MA. You will own deviations, perform RCA, and drive CAPA through closure while collaborating across Manufacturing, Quality, Engineering, Validation, and Operations.

The role requires 5+ years in the medical-device space with strong knowledge of FDA requirements and QMS. Hands-on problem-solving, documentation, and cross-functional teamwork are essential as you support remediation efforts.