MedTech Quality Engineer - Compliance & Process Excellence

Branch Medical Group; Memphis (TN); On-site; USD 70,000 - 95,000; Full time

Job summary

Globus Medical is seeking a Quality Assurance professional to design, implement, and maintain QA protocols for manufacturing processes and finished products. You will ensure compliance with FDA/state regulations and ISO 13485 standards across US and international operations.

The role involves inspecting processes, investigating quality issues, and supporting design control activities including risk assessment and validation.

Qualifications

• Proficient in computer technology including MS Office with strong analytical and problem-solving skills.
• Able to work efficiently in a team environment.
• Strong attention to detail and good organizational skills.
• Perform duties in compliance with FDA/state regulations and ISO 13485.

Responsibilities

• Reviews product and process changes for qualification and validation requirements and assists in change implementations.
• Implement systems to ensure timely quality inspections for incoming materials, components or finished goods and perform inspections as needed.
• Conduct investigations into complaints or audit issues as quality system feedback is provided.
• Supports Non-Conforming Material program and general Design Control activities including risk assessment, design verification, and validation, as well as sterilization and packaging validation.
• Assists with new quality initiatives, contributing to quality system development and procedure writing and review to improve product quality and reliability.
• Adheres to the company Code of Conduct, industry codes, and company policies.
• Ensures compliance with applicable laws and regulations in the US and internationally through training and ongoing knowledge.

Skills

MS Office proficiency

Analytical thinking

Attention to detail

Team collaboration

Regulatory compliance

Education

Bachelor’s degree in engineering

Job description

Globus Medical is seeking a Quality Assurance professional to design, implement, and maintain QA protocols for manufacturing processes and finished products. You will ensure compliance with FDA/state regulations and ISO 13485 standards across US and international operations.

The role involves inspecting processes, investigating quality issues, and supporting design control activities including risk assessment and validation.