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 seeks a Quality Engineer to help maintain ISO 13485 aligned processes, review specifications, and craft robust validation plans (IQ/OQ/PQ). You will run risk assessments, perform root-cause analyses of non-conformances, and apply quality tools to drive continuous improvement across manufacturing and product development.

Responsibilities include coordinating validation activities, ensuring proper documentation, and supporting supplier and customer requirements while

Qualifications

• College Degree or 4+ years QE experience.
• ISO 13485 experience or regulatory compliance knowledge.
• Experience evaluating specifications and design documents.
• Experience developing validation plans using IQ OQ PQ.
• Experience with FMEA and risk assessments.
• Ability to use quality tools for problem solving.

Responsibilities

• 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

Skills

Validation planning

IQ/OQ/PQ

FMEA & risk assessment

Root cause analysis

Quality tools

Customer feedback

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