Quality Systems Manager

Insight Global; Niles (IL); On-site; USD 90,000 - 125,000; Full time

Job summary

Insight Global seeks a Quality Systems Manager to lead the QMS for the Flexibles & Fluids division in Niles, IL. You will manage audits, CAPA, PPAP, and data-driven quality improvement across departments.

The role requires ISO 13485/21 CFR knowledge, Minitab and MS Office proficiency, and strong communication. Bachelor's degree and 1–2 years related experience are preferred.

Qualifications

• Experience in manufacturing, preferably medical device packaging/manufacturing.
• Bachelor’s degree and 1–2 years related experience or equivalent.
• Continuous improvement, Six Sigma training and/or certification preferred.
• Experience with ISO 13485 and 21 CFR Parts 11/820 for medical devices.
• Proficiency with Minitab or QA software and MS Office suite.

Responsibilities

• Maintain the QMS as Management Representative.
• Drive continuous quality improvement across departments.
• Manage verification/inspection activities and staff.
• Develop and control QMS documents and records.
• Lead CAPA, MRB, audits, PPAP, and risk analyses.
• Coordinate validations and generate quality performance reports.
• Provide failure analysis and lead improvement actions.

Skills

Continuous improvement

Excellent interpersonal skills

Good communication skills

Autonomy

Organized

Fluent English

Bilingual English/Spanish

QMS design & documentation

Attention to detail

Education

Bachelor's degree in a relevant field

Tools

Minitab

Microsoft Excel

PowerPoint

Quality auditing (CQAh)

ISO 13485 familiarity

Job description

Job Description

Our client a Global Materials 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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [e-mail] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• 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 Certified Quality Auditor preferred
• Bilingual (English/Spanish) preferred