Quality Specialist

Globus Medical•Memphis, TN

56d

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 : The Quality Specialist is responsible for designing, implementing and maintaining quality assurance protocols and methods for processing materials into finished products. Maintains sterile monitoring program and product release. Supports 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. Assists in report production for trend analysis. Upholds the company's quality standards and testing systems to reflect efficiency, reliability and performance.

Requirements

High School diploma or equivalent required
Excellent verbal and written communication skills
Attention to detail
Self-starter
Advanced critical thinking and problems-solving skills
Proficiency in using Microsoft Office products
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485

Responsibilities

Maintains environmental monitoring program
Maintains product lot release program
Document and process returned tissue (hct/p) product.
Monitor all temperature and humidity sensors and alert appropriate department of OOS readings.
Generate NCRs as required.
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 uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Performs quality inspections, ensuring inspection results and documentation support the recommended disposition action
Processes actions from quality system feedback such as records review, non-conforming materials reports, corrective action reports, complaints, or audit reports
Assists with new quality initiatives, participating in quality system development and procedure writing and review to improve the quality and reliability of products