Quality Engineer

Globus Medical•Memphis, TN

12d

About The Position

Globus Medical’s Quality Engineer designs, implements, and maintains quality assurance protocols and methods for processing materials into finished products. The role guides manufacturing and production compliance with internal and external safety, quality, and regulatory requirements for worldwide distribution. It inspects, tests, and evaluates production processes and equipment for precision and accuracy; supports analysis of reports and production data to identify trends and recommend updates to quality standards and procedures; upholds quality standards and testing systems; and assists with documentation of production issues and errors. The position reviews product and process changes for qualification and validation requirements, implements systems for timely inspections of incoming materials, components, and finished goods, and performs inspections as needed. It investigates complaints and audit issues, supports the Non-Conforming Material program and Design Control activities, and participates in risk assessment, design verification and validation, and sterilization and packaging validation. The Quality Engineer also contributes to quality initiatives, quality-system development, and procedure writing and review. The role requires compliance with company policies and applicable U.S. and international laws and regulations, and professional, ethical interactions with employees, customers, suppliers, and other third parties.

Requirements

Proficient with computer technology, including MS Office applications.
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 applicable FDA and state regulations and standards, including ISO 13485.
Typically requires a bachelor’s degree and a minimum of 2 years of related experience, an advanced degree without experience, or equivalent work experience.
Bachelor’s degree in an engineering discipline.

Responsibilities

Review product and process changes for qualification and validation requirements and assist with change implementations.
Implement systems to ensure timely quality inspections of incoming materials, components, and finished goods, and perform inspections as needed.
Investigate complaints and audit issues reported through quality-system feedback.
Support the Non-Conforming Material program and Design Control activities, including risk assessment, design verification and validation, and sterilization and packaging validation.
Assist with new quality initiatives and participate in quality-system development and procedure writing and review.
Follow the company Code of Conduct, applicable industry codes, and other company policies.
Maintain compliance with applicable governmental laws, rules, and regulations in the United States and internationally, including required introductory and annual training.
Represent the company professionally and uphold ethical business practices and socially responsible conduct in interactions with employees, customers, suppliers, and other third parties.
Design, implement, and maintain quality assurance protocols and methods for processing materials into finished products.
Guide manufacturing and production processes to meet internal and external safety, quality, and regulatory requirements.
Inspect, test, and evaluate the precision and accuracy of production processes and equipment.
Support analysis of reports and production data to identify trends and recommend updates to quality standards and procedures.
Assist in creating documentation to report production-process issues and errors.