QUALITY INSPECTOR

By | September 4, 2025

QUALITY INSPECTOR

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Job ID: 9953686

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Bloomingdale, IL, US

Electronic Assembly

Certification

Full Time, Temporary

$25.00

Experienced (Non-Manager)

On-site

Manufacturing - Other

First Shift (Day)

Bloomingdale, IL, US

$25.00

Experienced (Non-Manager)

Full Time, Temporary

Manufacturing - Other

On-site

Electronic Assembly

Certification

First Shift (Day)

Apply Now Applied

Job details

IF INTERESTED ON THE FOLLOWING POSITON, PLEASE CALL OR TEXT SARA AT 8473233840 OR EMAIL HER AT SARA062@KELLYSERVICES.COM
Position Summary
The Quality Inspector is responsible for ensuring that all medical imaging devices and components meet internal specifications, industry standards, and regulatory requirements. This position plays a key role in upholding Del Medical’s commitment to product quality, reliability, and safety in accordance with FDA, ISO 13485, and cGMP standards.

Key Responsibilities

  • Inspect incoming raw materials, subassemblies, and finished products using visual, mechanical, and electronic methods.

  • Perform in-process and final inspections of medical devices according to defined work instructions, control plans, and technical drawings.

  • Document inspection results accurately using quality records, inspection reports, and non-conformance reports.

  • Identify and escalate non-conformances and work collaboratively with engineering and production to support root cause analysis and corrective actions (CAPA).

  • Verify calibration status of inspection and test equipment before use.

  • Support internal and external audits by preparing inspection documentation and participating in audit activities.

  • Assist in the development and improvement of quality inspection procedures and protocols.

  • Ensure adherence to Del Medical’s Quality Management System (QMS), including compliance with FDA 21 CFR Part 820 and ISO 13485.

  • Participate in continuous improvement efforts, including 5S, Lean, and Kaizen initiatives.

Qualifications
Required:

  • High school diploma or GED; associate degree or technical certification in quality, electronics, or manufacturing preferred

  • 2+ years of experience as a quality inspector in a regulated industry (medical devices strongly preferred)

  • Strong understanding of mechanical drawings, GD&T, and inspection tools (e.g., calipers, micrometers, multimeters)

  • Familiarity with FDA regulations, ISO 13485, and cGMP

  • Experience with ERP and QMS systems for documentation and tracking (e.g., SAP, IQMS, or similar)

  • Excellent attention to detail, communication skills, and problem-solving ability

Preferred:

  • IPC certification (e.g., IPC-A-610)

  • Experience working with radiographic or imaging systems

  • Training in root cause analysis tools (e.g., 5 Whys, Fishbone Diagram)

Knowledge

  • Medical Device Quality Systems: Strong working knowledge of FDA 21 CFR Part 820, ISO 13485, and cGMP compliance.

  • Inspection Techniques: Understanding of visual, dimensional, mechanical, and electronic inspection methods for complex electro-mechanical assemblies.

  • Blueprints & GD&T: Ability to read and interpret engineering drawings, schematics, and geometric dimensioning and tolerancing (GD&T).

  • Calibration Standards: Knowledge of calibration procedures and metrology tools (e.g., calipers, micrometers, multimeters, torque drivers).

  • Root Cause & CAPA: Understanding of nonconformance investigation, root cause analysis, and corrective/preventive action procedures.

  • Manufacturing Processes: Familiarity with cleanroom or controlled environments, ESD-sensitive components, and final assembly protocols.

Skills

  • Attention to Detail: Highly accurate inspection and documentation; ability to detect deviations that could impact product safety or efficacy.

  • Technical Proficiency: Skilled in using measuring equipment and quality tools, such as control charts, checklists, and NCR forms.

  • ERP/QMS Systems: Competent in digital documentation systems (e.g., SAP, IQMS, or MasterControl).

  • Problem Solving: Able to quickly assess quality issues, interpret data, and support fast, compliant resolution.

  • Communication: Clear, concise reporting and effective collaboration with Quality, Engineering, and Production teams.

Abilities

  • Decision Making: Ability to make real-time go/no-go decisions based on defined criteria.

  • Prioritization: Able to manage time effectively under inspection deadlines.

  • Compliance Focus: Consistent commitment to regulatory adherence and documentation integrity.

  • Team Collaboration: Works well in cross-functional environments and supports team-based quality initiatives.

Key Performance Indicators

Quality & Inspection Metrics

  • First-Pass Yield (FPY): % of products passing inspection without rework or rejection.

  • Inspection Accuracy Rate: Number of inspection errors or missed non-conformances over total inspections performed.

  • Non-Conformance Rate: Number of product non-conformances identified per inspection batch or shift.

  • Rework Rate: % of inspected parts requiring rework due to missed or incorrect quality check.

  • Timely Inspection Completion: % of inspections completed within required time window (e.g., 24 hours for incoming parts).

  • Corrective Action Closure Time: Average time to resolve quality issues requiring CAPA (where involved).

Compliance & Documentation

  • Audit Readiness Score: Zero or minimal findings during internal or external quality audits (FDA, ISO, etc.).

  • QMS Documentation Accuracy: % of quality records correctly filled out and completed (e.g., no missing signatures, incomplete NCRs).

  • Training Completion Rate: 100% up-to-date training on relevant SOPs, work instructions, and regulatory standards.

Process Improvement & Engagement

  • Suggestions Submitted for Improvement: Number of quality/process improvement suggestions or Kaizen events supported.

  • Participation in Quality Initiatives: Attendance and engagement in quality team meetings, audits, or improvement projects.

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