$125,000–$130,000 Per Year
AS 9100, Aerospace and Defense, Auditing, Biology, Biotech and Pharmaceutical, Calendar Management, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Customer Support/Service, Document Control, Documentation, External Audit, FDA (Food and Drug Administration), FDA Requirements, Government, ISO (International Organization for Standardization), ISO 9001, Information Technology/Systems Audit, Internal Audit, Maintain Compliance, Manufacturing, Manufacturing Systems, Medical Equipment, Mentoring, Multitasking, Organizational Development/Management, Organizational Skills, Process Improvement, Project/Program Management, Quality Assurance, Quality Management, Quality Metrics, Quality System Requirements (QSR), Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Systems Administration/Management, TL 9000, TS 16949, Time Management, Training Program Development, Training/Teaching, Trend Analysis
Quality Compliance Manager
Location: Buffalo Grove, IL
Hire Type:Direct Hire | Full-Time | 100% Onsite
Compensation: $125,000–$130,000 Base Salary + 10% Annual Bonus
Benefits: Comprehensive benefits package including medical, dental, vision, 401(k), paid time off, paid holidays, and additional company-sponsored benefits.
Overview
We are seeking an experienced **Quality Compliance Manager** to lead Quality Systems and Regulatory Compliance activities within a highly regulated medical device manufacturing environment. This individual will play a critical role in maintaining compliance with FDA regulations, ISO standards, and internal quality systems while serving as the site lead for internal audit programs and supporting external customer and regulatory audits.
The ideal candidate is a hands-on quality professional with strong experience managing quality systems, leading internal audits, driving corrective actions, and partnering cross-functionally with Manufacturing, Engineering, Operations, and Regulatory Affairs to ensure ongoing compliance and continuous improvement.
Key Responsibilities
* Lead and support the site's Quality Compliance function, ensuring compliance with all regulatory and quality system requirements.
* Develop, implement, and maintain internal Quality Management System (QMS) audit programs.
* Plan, schedule, and execute internal quality system audits across manufacturing and support functions.
* Prepare audit plans, audit checklists, reports, and maintain all required audit documentation.
* Identify quality trends, nonconformances, and opportunities for continuous improvement through audit findings and quality metrics.
* Drive corrective and preventive actions (CAPA), ensuring timely implementation and effectiveness verification.
* Serve as the primary quality representative during customer, regulatory, certification, and government agency audits.
* Ensure compliance with FDA regulations, ISO standards, customer requirements, and internal quality procedures.
* Partner with Manufacturing, Engineering, Regulatory Affairs, and Operations teams to implement quality system improvements.
* Develop and deliver training programs related to quality systems, regulatory requirements, and audit readiness.
* Mentor and develop quality personnel while promoting a culture of quality and continuous improvement.
* Maintain audit records and ensure compliance documentation is inspection-ready at all times.
Required Qualifications
* Bachelor's degree in Engineering, Quality, Life Sciences, or another related technical discipline.
* Minimum **6 years of experience** in Quality Systems, Quality Compliance, Quality Assurance, or Regulatory Compliance within a regulated manufacturing environment.
* Strong experience planning and leading internal quality system audits.
* Experience supporting customer, FDA, ISO, or third-party regulatory audits.
* Working knowledge of Quality Management Systems (QMS), CAPA, document control, and regulatory compliance.
* Excellent communication skills with the ability to influence cross-functional teams.
* Strong organizational skills with the ability to manage multiple priorities in a fast-paced manufacturing environment.
Preferred Qualifications
Experience working within one or more of the following quality standards:
* ISO 13485
* ISO 9001
* AS9100
* IATF 16949 / ISO TS16949
* TL9000
Experience supporting medical device, pharmaceutical, aerospace, or other highly regulated manufacturing environments is strongly preferred. A successful candidate is a proactive quality leader who enjoys working on the manufacturing floor, partnering with cross-functional teams, and ensuring world-class quality system compliance. They possess strong audit experience, thrive in regulatory environments, and have a proven track record of driving quality improvements while preparing organizations for successful customer and regulatory inspections.