Quality Systems Manager

Insight Global; Niles (IL); On-site; USD 85,000 - 120,000; Full time

Job summary

Insight Global is assisting a Global Chemical Manufacturer in Niles, Illinois, to hire a Quality Systems Manager. This role ensures QMS integrity, drives continuous improvement, and maintains ISO 13485 compliance across packaging/medical devices divisions.

The ideal candidate has a Bachelor's degree with 1–2 years of related experience, Six Sigma training, and strong data analysis and MS Office skills. The position requires autonomy and strong communication.

Qualifications

• Bachelor’s degree and 1–2 years related experience, or equivalent combination of education and experience.
• Six Sigma training or certification preferred.
• Experience with ISO 13485 and 21 CFR Parts 11 and 820 for medical devices.
• Experience with Minitab or other QA software preferred.
• Strong proficiency in Microsoft Office (Excel, PowerPoint, Word).
• Excellent interpersonal skills and ability to work with autonomy.
• Demonstrated ability to design and maintain quality management systems with attention to detail.

Responsibilities

• Maintain the Quality Management System (QMS) as Management Representative.
• Drive continuous quality improvement across departments.
• Maintain QMS certifications (e.g., ISO 13485).
• Manage QA inspections and QA staff.
• Develop QMS documents and manage document control.
• Lead CAPA and MRB processes for non-conformances with root-cause analysis.
• Perform statistical analysis of processes and product conformance (Minitab).
• Lead internal/external audits of the QMS and report on quality performance.
• Support training to ensure ongoing QMS effectiveness.

Skills

QMS Development

ISO 13485

Six Sigma

Minitab

CAPA

Process Improvement

Data Analysis

Excel

Documentation

Communication

Autonomy

Team Leadership

PowerPoint

Word

Education

Bachelor's degree

Tools

Minitab

Quality software

Job description

Our client a Global Chemical Manufacturer, is looking to add a Quality Systems Manager to their Flexibles & Fluids Division in Niles, Illinois.

General Description of Duties

• Management Representative to Maintain the Quality Management System (QMS)
• Interface with all internal departments in order to drive continuous quality improvement within the organization
• Maintain certification of the QMS to applicable standards as determined by executive management (e.g. ISO 13485)
• Manage the company’s verification (inspection) activities including quality inspection staff
• Develop and write QMS documents (procedures, work instructions, forms, etc.) and manage document control to comply with customer, company, and regulatory requirements.
• In conjunction with the Material Review Board (MRB) manage the resolution of non-conformances using root cause analysis, corrective/preventive action (CAPA) plans, and verification of effectiveness
• Analysis and management of risk, using such tools at FMEA (Failure Mode and Effects Analysis)
• Perform statistical analysis of processes and product conformance using methods such as Minitab “6-packs”, and other statistical tools
• Measure and improve metrology (measuring) system performance, including Gage R&R studies
• Provide failure analysis for items returned from customers or from production retain samples
• Execute the Production Part Approval Process (PPAP) per customer requirements
• Coordinate internal and customer requested validations of processes, equipment, and materials
• Track and document Improvement Action Reports (IARs)
• Compile metrics related to the Quality Management System (QMS) and department objectives and prepare reports on quality performance data
• Lead the development of quality goals
• Create and conduct training classes for production and administrative personnel in order to ensure the on-going effectiveness and improvement of the QMS
• Compile and analyze metrics regarding product quality and recommend corrective action necessary to ensure conformity with quality specifications and standards
• Lead the internal and external Audit Program and identify opportunities to refine processes and practices where possible to improve the overall value of the QMS
• Other duties as assigned.

Required Skills and Experience

• Prior experience in manufacturing, preferably in medical device packaging or medical device manufacturing
• Bachelor’s degree from a four-year college or university and one to two years related experience and/or training; or equivalent combination of education and experience
• Continuous improvement, Six Sigma training and/or certification preferred
• Experience with ISO 13485 and 21 CFR Parts 11 and 820 for medical devices
• Experience with Minitab or other QA software preferred
• Strong proficiency in Microsoft Office software including Excel, PowerPoint and Word
• Excellent interpersonal skills
• Prior experience working with a high level of autonomy
• Demonstrated experience in being well-organized, able to design quality management systems, and detail oriented
• Good communication skills with the ability to speak, read, and write English fluently