Apply on Employer Site

ARxIUM · 22 hours ago

Quality Inspector

Buffalo Grove, IL

Full-time

Onsite

Entry Level

1+ years exp

ARxIUM is a leader in pharmacy automation, offering innovative hardware and software solutions globally. The Quality Inspector position is responsible for performing quality inspection and acceptance of components and products, ensuring manufacturing quality through various testing and documentation processes.

Health CareMedicalMedical Device

H1B Sponsor Likely

Responsibilities

Comply with applicable FDA regulations and ISO 13485 requirements

Adhere to company Quality Management System (QMS)

Responsible for performing and documenting incoming, in-progress and final product acceptance testing

Creates inspection documents and maintains the incoming inspection room

Verify that documents required of suppliers, such as certificates of conformance and first article inspection results are provided for incoming goods, which include materials, parts, assemblies, machines, accessories, electronic devices, PCBs, and fabricated metal parts

Use standard measuring instruments, gages and controlled components to verify functional fit and dimensional checks. Test incoming goods, such as electronic devices and PCBs

Develop and maintain incoming inspection files and records

Document in-house inspection results

Responsible for updating and maintenance of manufacturing product files upon final inspection and acceptance of products

Logs defects in QA defect management reporting system. Assists in analysis as deemed necessary

Maintain records for inspection data and unplanned events

Creates detailed Quality Reports as required. Responsible for initiating non-conformance reports and working with Engineering and Manufacturing for the resolution of problems. Additionally, responsible for reviewing the disposition of parts, sub-assemblies and product as well as releasing finished goods into inventory

Take part in root cause analysis and support corrective and preventive actions

Work with Supply Chain in returning nonconforming goods to suppliers

Maintain calibration program, including reviews and approvals of calibration reports

Analyze problems and recommend changes. Support FDA inspections, external and internal ISO audits

Maintain a safe work environment

Performs related duties as assigned

Qualification

ISO 13485FDA regulationsQuality Management SystemIncoming inspection techniquesCalibration system maintenanceFirst article inspectionAnalytical problem solvingMeticulous documentationComputer skillsCollaboration skills

Required

Comply with applicable FDA regulations and ISO 13485 requirements

Adhere to company Quality Management System (QMS)

Responsible for performing and documenting incoming, in-progress and final product acceptance testing

Creates inspection documents and maintains the incoming inspection room

Use standard measuring instruments, gages and controlled components to verify functional fit and dimensional checks. Test incoming goods, such as electronic devices and PCBs

Develop and maintain incoming inspection files and records

Document in-house inspection results

Responsible for updating and maintenance of manufacturing product files upon final inspection and acceptance of products

Logs defects in QA defect management reporting system. Assists in analysis as deemed necessary

Maintain records for inspection data and unplanned events

Take part in root cause analysis and support corrective and preventive actions

Work with Supply Chain in returning nonconforming goods to suppliers

Maintain calibration program, including reviews and approvals of calibration reports

Analyze problems and recommend changes. Support FDA inspections, external and internal ISO audits

Maintain a safe work environment

Performs related duties as assigned

Superior interpersonal skills

Articulate verbal and written communication

Well-developed organizational and planning skills

Collaboration and consensus building in a team environment

Self-motivated—works independently with little supervision

Analytical and resourceful problem solving

Isolation of key issues from complex information

Identification of patterns and trends in unplanned events and non-conformances

Meticulous documentation and recordkeeping habits

Calibration system maintenance

Intermediate Computer skills: Microsoft Office Suite (including PowerPoint, Office, Outlook, Visio, Word, Excel)

Functional understanding of the ISO 13485 International Standard

Practical knowledge of the FDA Code of Federal Regulations (CFR), Title 21, Part 820

QMS requirements, including nonconformance reporting (NCR), corrective and preventive action (CAPA)

Incoming, in-process, and outgoing inspection techniques

Use of gages and standard measuring instruments

Familiar with current good manufacturing practices (cGMP)

Understanding of common manufacturing processes

Knowledge of first article inspection (FAI) and certificates of conformance (CofC)

Support of FDA inspections; external and internal ISO audits

High School degree or equivalent

1-2 years in a quality assurance role in a government-regulated industry—medical device manufacturing preferred

Preferred

Associate degree preferred

Benefits

Medical, dental, and vision benefits or Health Spending Account

Company-paid life/ADD insurance

401k

Flexible work schedule and generous paid time off

Competitive salary

Company

ARxIUM

ARxIUM delivers best-in-class technology and unparalleled expertise focused on helping pharmacies of all sizes and types improve safety.

Founded in 2015

Buffalo Grove, Illinois, USA

201-500 employees

https://www.arxium.com

H1B Sponsorship

ARxIUM has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (1)

2024 (1)

2021 (1)