Quality Control Inspector I

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.

Essential Functions

• 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

Qualifications

• 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
• 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