Quality Engineer

Globus MedicalMemphis, TN
7d

About The Position

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary: Designs, implements, and maintains quality assurance protocols and methods for processing materials into finished products. Guides the compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standard requirements for worldwide distribution. Inspects, tests and evaluates the precision and accuracy of production processes and equipment. Supports the analysis of reports and production data to help identify trends and recommend updates or changes to quality standards and procedures. Upholds the company's quality standards and testing systems to reflect efficiency, reliability, and performance. Assist in the creation of documentation to report issues and errors relating to the production process.

Requirements

  • Proficient in computer technology including MS Office applications, 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 applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485
  • Typically requires a bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
  • Bachelor's degree in engineering discipline

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 products, and perform inspections as needed.
  • Conduct investigations into complaints or audit issues as quality system feedback is provided.
  • Supports the Non-Conforming Material program and general Design Control activities such as risk assessment, design verification, and validation, as well as sterilization and packaging validation.
  • Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products.
  • Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
  • Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
  • Represents the company in a professional manner and upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.
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