Quality Control Inspector I

Globus Medical•Eagleville, PA

14d

About The Position

Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures implants for spinal and orthopedic applications and designs instrumentation cases. The Quality Control Inspector performs inspections at various production stages, from raw materials onward, and provides quality assurance support as needed. The role works with other quality control inspectors and engineers to help ensure products and assignments meet company requirements. The position handles inspection records and controlled documentation, supports timely release of subassemblies and assemblies, and manages nonconforming materials and component or assembly dispositions. It also coordinates with cross-functional teams, supports external audits as directed, and carries out responsibilities in accordance with applicable company policies, regulations, and ethical standards. The work takes place in a production area or clean room, with some exposure to noisy equipment. The role involves lifting and moving materials, a range of postures and movements, and specific visual abilities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

Quality Inspector qualification or advanced studies in a relevant technical discipline.
At least three years of directly related experience.
Ability to read and interpret job travelers, plans, sketches, diagrams, procedures, and other documents.
Fundamental knowledge of geometry, fractions, percentages, relationships, and measurements.
Ability to work independently with little supervision and as part of a team.
Effective interpersonal skills and ability to work with a culturally diverse employee population.
Strong organizational and follow-up skills.
Excellent verbal and written communication skills.
Attention to detail and ability to work as a self-starter.
Advanced critical-thinking and problem-solving skills.
Proficiency with Microsoft Office products.
Ability to meet the stated physical demands, including sitting, climbing or balancing, stooping, kneeling, crouching or crawling; regularly lifting or moving up to 25 pounds and occasionally up to 50 pounds; and possessing close, distance, color, and peripheral vision, depth perception, and the capacity to adjust focus.

Nice To Haves

Experience inspecting in a Class II or III medical device environment; complaints lab inspection or receiving inspection experience is also preferred.
Medical device industry experience and knowledge of performing the role under FDA Quality System Regulations (QSRs) and ISO 13485.
Experience with QAD.
Prior experience working with U.S. companies.
IPC-A-610 certification or knowledge of medical device component welding, including resistance, spot, or laser welding.
Experience handling electrical components.
Experience with ESD processes.
Knowledge of measurement instruments and sample plans.
Experience inspecting small parts under magnification, including with a microscope.

Responsibilities

Inspect products and production raw materials to ensure they meet customer or internal standards.
Handle applicable fixtures and equipment correctly.
Use quality inspection records in accordance with GMP requirements.
Edit and proofread documentation for consistency and quality before sending it to the documentation center.
Maintain and archive documents in an organized, retrievable format to support compliance with procedures, regulations, and standards.
Safeguard in-process inspection quality records.
Schedule periodic document reviews to ensure documents comply with Globus requirements, processes, and external regulations.
Communicate corrections and opportunities for improvement.
Release subassemblies and assemblies in a timely manner by executing, reviewing, and approving Device History Records (DHRs) and ERP transactions according to internal requirements.
Control nonconforming material, including identification and segregation.
Work with cross-functional teams to ensure internal and external compliance requirements are followed and implemented.
Label and segregate components and assemblies.
Notify Production, Quality, Purchasing, and other relevant departments about component or assembly dispositions and material holds.
Manage component and assembly dispositions and queries using the QAD system.
Support external audit activities when required and directed.
Release subassemblies, assemblies, and final assemblies.
Follow the company Code of Conduct, applicable industry codes, and company policies; complete required compliance training and maintain role-related compliance knowledge.
Represent the company professionally and uphold ethical business practices and socially responsible conduct in interactions with employees, customers, suppliers, and other third parties.