Find & Apply For Quality Inspector / Technician Jobs in Mount Prospect, Illinois

Job Summary Work Environment:

This role requires high-level coordination and logistics support between the Quality department and other functional areas (Production, Business Development, Logistics). The candidate must be comfortable working on the "floor" during surveillance while maintaining the administrative discipline required for documentation and record control.

Role Summary:

The Quality Specialist is responsible for ensuring the highest standards of operational excellence by maintaining oversight of manufacturing, laboratory, and operational processes. You will serve as a key guardian of compliance, ensuring that all activities align with Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and the requirements of

ISO 9001, ISO 22716, ISO

13485, and FDA's Quality Management System Regulation (QMSR, 21 CFR Part 820). This role is critical in the support of document and record control, change control, investigations, site performance reporting, Management Review, and MDSAP, regulatory, and other internal and external audits to drive continuous improvement across the organization. Process Surveillance & Compliance Conduct routine surveillance of manufacturing and laboratory operations to ensure strict adherence to SOPs and GMP best practices. Verify the identification and traceability of bulk lots, process lots, finished products, and equipment. Monitor personnel training records to ensure all staff are current on required competencies. Perform rigorous review and verification of operational and quality control records to ensure data integrity. Document & Record Control Administer the controlled document lifecycle within the QMS — creation, review, approval, revision, distribution, and obsolescence — ensuring only current, approved versions are in use at the point of use. Maintain accurate revision histories, document numbering, and effective dates; issue and reconcile controlled copies and remove superseded documents from circulation. Issue, track, and reconcile controlled forms, logbooks, and batch/production records; verify that completed records are legible, complete, and compliant with Good Documentation Practices (GDP) and data integrity expectations (ALCOA+). Manage record retention, archival, retrieval, and secure destruction schedules in line with regulatory and corporate requirements, and support record retrieval requests during audits and investigations. Maintain quality system logs and registers (deviations, nonconformances, CAPAs, change controls, complaints, training) so that status and traceability are current and audit-ready at all times. Support periodic document review cycles, ensuring SOPs, work instructions, specifications, and forms are reviewed and revised on schedule. Site-Specific Performance Review & Data Gathering Gather, compile, and verify site-specific quality data and KPIs (deviations, nonconformances, CAPA closure rates, complaint rates, right-first-time, on-time record review, training compliance, audit findings) across all RPIGoC locations. Prepare recurring site-level quality performance reports, trend analyses, and dashboards for monthly quality reviews and Management Review, ensuring data accuracy and consistency of definitions across sites. Identify adverse trends, recurring failure modes, and site-to-site variation; escalate findings and support the development of data-driven improvement actions. Track the status and effectiveness of open quality system items and provide status reporting to the Quality Manager and site leadership. Partner with Production, Lab, and Logistics to collect supporting data and validate metric inputs at the source.

Change & Deviation/Nonconformance Management Change Control:

Support the Management of Change (MOC) process via the QMS system; ensure no changes occur without formal approval and management consultation, and that all associated documents are updated and released before implementation.

Deviation Handling:

Immediately notify management of deviations; document and route deviations through the formal approval workflow.

Nonconformance/CAPA:

Identify, segregate, and document nonconforming materials. Assist management in determining the final disposition of these materials. Investigations & Root Cause Analysis Document investigations for customer complaints and process deviations. Perform deep-dive Root Cause Analysis (RCA) using industry-standard tools such as 5-Whys and 6M (Ishikawa). Implement approved Corrective and Preventive Actions (CAPA) and track their long-term effectiveness. Audit Support & Continuous Improvement Provide comprehensive support for internal and external audits across all sites, including customer, notified body/registrar, regulatory, and MDSAP audits. Support MDSAP audit readiness and execution using the MDSAP Audit Model process-based approach, and maintain evidence aligned to the participating regulatory jurisdictions. Prepare and review technical documentation to ensure audit readiness, including the quality manual, procedures, records, and process linkages required under ISO 13485 and

ISO 9001.

Facilitate the timely closure of audit findings and observations, including responses, corrections, and CAPA evidence packages. Support continuous improvement initiatives and update quality procedures, work instructions, and training materials. Coordination and logistics support between Quality and other departments. QMSR Compliance & Management Review Support Support compliance with FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, which incorporates

ISO 13485

2016 by reference along with FDA's supplemental requirements in Subparts A and B. Maintain records and controls required by the FDA-specific provisions retained in the QMSR, including §820.35 record requirements (unique device identification, complaint records, and servicing records) and §820.45 device labeling and packaging controls. Ensure quality system documentation and terminology remain aligned to the QMSR framework (e.g., medical device file per

ISO 13485

clause 4.2.3) and that legacy QSR-era references are retired as procedures are revised. Support readiness for FDA inspections conducted under the process-based inspection model, recognizing that management review, internal audit, and supplier audit reports are subject to FDA review under the QMSR. Compile and prepare Management Review inputs — audit results, customer feedback and complaints, process and product conformity, deviation/NC and CAPA status, supplier performance, changes affecting the QMS, and status of actions from previous reviews. Draft and maintain Management Review agendas, presentation packages, minutes, and action item logs; track assigned actions to closure. Assist management in reporting QMS performance and improvement opportunities to top management, and in promoting awareness of applicable regulatory and customer requirements throughout the organization. Maintain records of correspondence with regulatory agencies and certification bodies at the direction of the Quality Manager.

Qualifications & Requirements Minimum Education:

Bachelor's degree in Life Sciences, Chemistry, Engineering, or related technical field.

Experience:

Minimum of 3 years of direct experience in a Quality Assurance role. Strong working knowledge of

ISO 9001, ISO 22716

(Cosmetic GMP), and

ISO 13485

(Medical Device QMS). Working knowledge of FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820; experience operating under QMSR is highly preferred. Working knowledge of the Medical Device Single Audit Program (MDSAP) and its audit model; direct experience preparing for or supporting an MDSAP audit is highly preferred. Demonstrated experience with document and record control within a controlled/GMP environment. Experience preparing Management Review inputs and supporting regulatory inspections or certification audits is preferred. Proven background in change management, root cause analysis, quality metrics reporting, and technical document review.

Technical Skills & Attributes Integrity:

Demonstrates uncompromising adherence to ethical standards, transparency in reporting, and a commitment to quality and safety above all else.

Organized and Self-Starter:

Proven ability to manage your own schedule, prioritize tasks effectively, and take initiative without constant supervision.

Analytical Thinking:

Proficiency in problem-solving, data analysis, and identifying systemic issues.

Communication:

Exceptional written and verbal skills for cross-departmental coordination.

Detail Oriented:

High level of precision in record verification, document control, and compliance monitoring.

Adaptability:

Ability to multi-task and thrive in a fast-paced, high-pressure environment.

Software:

Experience with Quality Management Systems is highly preferred; proficiency in Excel (pivot tables, charts) or comparable tools for compiling and presenting quality data.

Pay:

$50,000.00 - $60,000.00 per year

Benefits:

401(k) matching Health insurance Health savings account Paid time off Professional development assistance

Education:

Bachelor's (Required)

Experience:

QA:

3 years (Required)

ISO 9001, ISO 13485

3 years (Required) c

GMP:

3 years (Required)

Work Location:

In person