Type:

full-time

Job Description:

Quality Assurance Project 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. 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