QA & Validation Engineer – ISO 13485 & NPD Support

Midland-Marvel Recruiters, LLC; Latrobe (Westmoreland County); On-site; USD 70,000 - 110,000; Full time

Job summary

Midland-Marvel Recruiters, LLC is seeking a Quality Engineer to support and maintain an ISO 13485 compliant Quality Management System. The role focuses on evaluating specifications and design documents, developing comprehensive validation plans (IQ/OQ/PQ), and coordinating validation activities to ensure regulatory and customer requirements are met.

The successful candidate will execute FMEAs and risk assessments, investigate non-conformances, and drive corrective actions using established

Qualifications

• Establish and maintain ISO 13485 based QMS
• Provide feedback on specifications, requirements and design documents
• Develop and execute FMEAs and risk assessments with internal/external teams
• Plan, estimate and coordinate validation activities to meet regulatory and customer requirements
• Complete validation documentation per requirements
• Investigate non-conformances and drive corrective actions
• Utilize quality tools for problem solving and improvements
• Support new product development and manufacturing to meet customer expectations
• Manufacturing Safety
• College Degree or 4+ years QE experience

Responsibilities

• Establish and maintain ISO 13485 compliant processes and procedures
• Review specifications and design documents to provide actionable feedback
• Create validation plans using IQ/OQ/PQ structure and coordinate execution
• Perform FMEA and risk assessments with cross-functional teams
• Investigate root causes of non-conformances and implement corrective actions
• Apply quality tools to identify opportunities for improvement
• Assist new product development and production to meet customer expectations
• Ensure manufacturing safety practices are followed

Skills

Quality Management

FMEA

Risk assessment

Root cause analysis

Quality tools

Education

College degree

Job description

Midland-Marvel Recruiters, LLC is seeking a Quality Engineer to support and maintain an ISO 13485 compliant Quality Management System. The role focuses on evaluating specifications and design documents, developing comprehensive validation plans (IQ/OQ/PQ), and coordinating validation activities to ensure regulatory and customer requirements are met.

The successful candidate will execute FMEAs and risk assessments, investigate non-conformances, and drive corrective actions using established