Quality Control Inspector

Globus Medical•Eagleville, PA

15d

About The Position

Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures a wide range of implants for spinal and orthopedic applications as well as design the instrumentation cases that house them. Our passion, combined with Globus’ world-class engineering, transforms clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care and understand that speed is critical because life cannot wait. Position Summary : The Quality Control Inspector is responsible for performing inspections at various stages of production of the product from raw material. This effort includes, but is not limited to, providing QA support, where needed, but not limited to QA Operations. This individual works with other quality control inspectors and engineers to ensure products or assignments align with the companies.

Requirements

Quality Inspector or advanced studies in relevant technical discipline required
No fewer than three (3) years of directly related experience, having experience in a class II or III medical device environment quality inspection is preferred, complaints lab inspection or receiving inspection is also preferred, inspection small components using a microscope is preferred
Experience in the medical device industry and with knowledge performing their function within the Food & Drug Administration (FDA), Quality System Regulations (QSRs), International Organization of Standardization (ISO 13485) is preferred
Experience with QAD preferred
Prior experience working with US companies is a plus
IPC-A-610 certification or knowledge in medical device component welding through resistance welding, spot welding or laser welding is a plus
Handling of electrical components is a plus
Experience with ESD processes is a plus
Ability to read and interpret documents such as job travelers, plans, sketches, diagrams and other procedural materials and documents
Fundamental geometry, fractions, percents, relationships and measurements
Ability to work independently with little supervision, as well as in "team" work
Effective interpersonal skills and dexterity on the job with a culturally diverse employee population
Knowledge of measurement instruments, sample plans is a plus
Experience with inspecting small parts under magnification is a plus
Required to sit; climb or balance; and stoop, kneel, crouch or crawl
Required to regularly lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds
Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.
Strong organizational and follow-up skills
Excellent verbal and written communication skills
Attention to detail
Self-starter
Advanced critical thinking and problems-solving skills
Proficiency in using Microsoft Office products

Responsibilities

Carries out inspection activities to ensure the quality of products and raw materials used in the production of products to meet customer or internal standards
Responsible for the correct handling of the corresponding fixtures and equipment
Correct use of quality inspection records following GMP requirements
Ensures the consistency and quality of records by editing and proofreading all documentation prior to handling it to the documentation center for storage
Maintains and archives documents in an organized and retrievable state (manual or electronic) for compliance to procedures, regulations and standards
Safekeeping all quality records of In-Process Inspection
Schedules periodic document reviews to ensure documents are compliant with Globus requirements and processes as well as external regulations
Communicates corrections and improvement opportunities
Ensures timely release of subassemblies and assemblies by executing, reviewing and approving Device History Records (DHRs) and ERP transactions per internal requirements
Responsible for the control of nonconforming material (identification, segregation)
Interfaces with cross functional team to ensure internal and external compliance requirements are followed and implemented per requirements
Labels and segregates components and assemblies
Notifies cross functional departments including Production, Quality and Purchasing on component/assembly dispositions and/or material holds
Manages component/assembly disposition and queries using the QAD system
Supports with External Audits activities when required and as directed
Responsible for the release of subassemblies, assemblies and final assemblies
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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.