Quality Assurance Engineer

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

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