Quality Engineer

Globus Medical•Memphis, TN

14d

About The Position

At Globus Medical, the team develops innovations intended to improve the quality of life of patients with musculoskeletal disorders. The company partners with researchers, educators, surgeons, and healthcare providers to turn clinical insights into solutions that improve surgical techniques and outcomes. The Quality Engineer designs, implements, and maintains quality assurance protocols and methods for processing materials into finished products. The role supports compliance of manufacturing and production processes with internal and external safety, quality, and regulatory requirements for worldwide distribution. It inspects, tests, and evaluates the precision and accuracy of production processes and equipment, supports analysis of reports and production data to identify trends and recommend quality-standard or procedure changes, and helps document production issues and errors. The role also supports product and process change qualification and validation, incoming and finished-product inspections, investigations, non-conforming materials, design control, and quality-system initiatives. Employees are expected to follow company policies and applicable laws and regulations, and to maintain professional and ethical conduct. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

Proficiency with computer technology, including MS Office applications.
Good analytical and problem-solving skills.
Ability 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 for timely quality inspections of incoming materials, components, or finished goods, and perform inspections as needed.
Conduct investigations into complaints or audit issues identified 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, procedure writing, and procedure review to improve product quality and reliability.
Follow the company Code of Conduct, the AdvaMed Code, the MedTech Code, and other company policies.
Complete introductory and annual compliance training and maintain knowledge of applicable U.S. and international governmental laws, rules, and regulations.
Represent the company professionally and uphold ethical business practices and socially responsible conduct in interactions with employees, customers, suppliers, and other third parties.
Help analyze 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.