Quality Assurance Engineer - Validation & Compliance Specialist

Midland-Marvel Recruiters, LLC; Latrobe (Westmoreland County); On-site; USD 70,000 - 90,000; Full time

Job summary

Midland-Marvel Recruiters, LLC is seeking a Quality Engineer to support the maintenance of the Quality Management System in compliance with ISO 13485 and regulatory expectations. The role involves defining product requirements, monitoring quality performance, and developing validation plans.

The ideal candidate will have a college degree or over 4 years of experience in quality engineering. Responsibilities include completing validation documentation and analyzing quality data to ensure product meets expectations.

Qualifications

• Experience with ISO 13485 and regulatory compliance.
• Ability to develop validation plans using IQ OQ PQ structure.
• Strong analytical and quality improvement skills.

Responsibilities

• Support the maintenance of the Quality Management System.
• Evaluate specifications and provide feedback.
• Ensure validation documentation is completed.
• Develop and execute quality assessments and investigations.

Skills

ISO 13485 compliance

Validation planning

Root cause analysis

FMEAs and risk assessments

Problem-solving techniques

Education

College Degree or 4+ years QE experience

Job description

Midland-Marvel Recruiters, LLC is seeking a Quality Engineer to support the maintenance of the Quality Management System in compliance with ISO 13485 and regulatory expectations. The role involves defining product requirements, monitoring quality performance, and developing validation plans.

The ideal candidate will have a college degree or over 4 years of experience in quality engineering. Responsibilities include completing validation documentation and analyzing quality data to ensure product meets expectations.