MedTech Quality Engineer - ISO 13485 & Compliance

NML Medical; Memphis (TN); On-site; USD 65,000 - 90,000; Full time

Job summary

Globus Medical seeks a QA professional to design, implement, and maintain QA protocols for processing materials into finished products. You will guide production compliance with safety, quality, and regulatory standards for worldwide distribution and support data analysis to identify trends and improve quality systems.

You will inspect, test, and evaluate processes and equipment, assist with documentation, and contribute to continuous improvement initiatives while upholding ethical practices and

Qualifications

• Proficient in MS Office with good 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 and ISO 13485 standards.
• Bachelor's degree in engineering discipline; typically requires 2 years of related experience or advanced degree.

Responsibilities

• Reviews product and process changes for qualification and validation requirements and assists in change implementations.
• Implements systems to ensure timely quality inspections for incoming materials, components or finished goods, and performs inspections as needed.
• Conducts investigations into complaints or audit issues as quality system feedback is provided.
• Supports non-conforming material program and design control activities including risk assessment, design verification and validation, sterilization and packaging validation.
• Assists with new quality initiatives, contributing to quality system development and procedure writing and review.
• Adheres to the Code of Conduct and applicable policies, ensuring compliance with laws and regulations.
• Represents the company professionally and upholds ethical business practices in all interactions.

Skills

Analytical ability

Teamwork

Attention to detail

MS Office

Education

Bachelor's degree in engineering

Tools

MS Office

Job description

Globus Medical seeks a QA professional to design, implement, and maintain QA protocols for processing materials into finished products. You will guide production compliance with safety, quality, and regulatory standards for worldwide distribution and support data analysis to identify trends and improve quality systems.

You will inspect, test, and evaluate processes and equipment, assist with documentation, and contribute to continuous improvement initiatives while upholding ethical practices and