Quality Assurance Engineer

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

Support the maintenance of the Quality Management System for compliance to ISO 13485 and appropriate regulatory bodies and customer agreements. Define requirements for new products, monitoring production quality performance to identify opportunities for improvement and support maintenance of quality files, procedures, and work instructions for proper adherence to the quality system.

• Evaluate specification, requirements, and design documents to provide prompt and valuable feedback to internal and external customers.
• Develop detailed and well-structure validation plans using IQ OQ PQ structure.
• Estimate, prioritize, plan and coordinate validation activities to ensure conformance to regulations, internal requirements and customer requirements.
• Ensure all validation documentation completed per requirements.
• Develop and execute FMEAs and risk assessments with internal and external teams as needed.
• Support investigation of root cause of non-conformances and corrective actions.
• Use quality tools to analyze and identify areas for improvements and problem solving techniques.
• Support new product development and production to ensure that the product meets customer expectations.
• Manufacturing Safety
• College Degree or 4+ years QE experience