Quality Control Inspector I

Globus Medical•Eagleville, PA

13d

About The Position

Branch Medical Group, a subsidiary of Globus Medical Inc., manufactures implants for spinal and orthopedic applications and instrumentation cases. The Quality Control Inspector performs inspections at various stages of production, from raw materials through subassemblies, assemblies, and final assemblies. The role provides quality assurance support as needed and works with other inspectors, engineers, and cross-functional teams to ensure products and assignments meet company, customer, regulatory, and internal requirements. The inspector uses and maintains inspection records and documentation in accordance with GMP requirements, manages in-process inspection records and document archives, supports document reviews, and processes Device History Records (DHRs) and ERP transactions. The role also identifies and segregates nonconforming materials, manages component and assembly dispositions through the QAD system, and supports external audits when directed. The position is based in a production area or clean room, with some exposure to noisy equipment. The employee must be able to meet the described physical demands, including lifting and moving materials and performing inspection work requiring specific visual abilities.

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.
Knowledge of fundamental geometry, fractions, percents, 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.
Strong verbal and written communication skills.
Attention to detail.
Self-starter with advanced critical-thinking and problem-solving skills.
Proficiency with Microsoft Office products.
Ability to meet the physical demands of the job, 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 close, distance, color, peripheral, and depth vision and the ability to adjust focus.

Nice To Haves

Experience in a Class II or III medical device environment, especially quality inspection; complaints lab inspection or receiving inspection experience is also preferred.
Experience in the medical device industry and knowledge of FDA Quality System Regulations 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 raw materials at various production stages to ensure they meet customer or internal standards.
Handle the corresponding fixtures and equipment correctly.
Use quality inspection records correctly in accordance with GMP requirements.
Edit and proofread documentation for consistency and quality before submitting it to the documentation center.
Maintain and archive documents in an organized, retrievable manner, manually or electronically, to comply with procedures, regulations, and standards.
Safekeep 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 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 cross-functional 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 relevant 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.