Quality Inspector Job Listing at Kelly Services in Bloomingdale, IL (Job ID US3601056_BH9953686)

Description

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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