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MAC Medical

Director of Quality Assurance & Regulatory Affairs

Pay: Not specified

Posted: 3 weeks ago

Location: Millstadt, IL (Onsite)

Last Updated: 3 weeks ago

Hours: Full-Time

Expires: 9/22/2026

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What they do

A Director of Quality Assurance oversees and directs the overall operations of quality assurance within a company to ensure continuous improvement and compliance.

$129,386 / year median in Illinois

-3% projected decline

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Job Description

Description:

MAC Medical, Inc.

Director of Quality Assurance & Regulatory Affairs Classification:

Exempt Reports To:

President Location:

Millstadt, Illinois Position Summary Provides strategic leadership of the Quality Management System (QMS), regulatory affairs, compliance programs, certifications, supplier quality governance, and customer quality systems. Essential Functions Own the corporate QMS. Lead FDA and ISO compliance. Manage regulatory submissions and audits. Maintain document control and change control. Own CAPA governance and Management Review. Oversee supplier qualification and audits. Manage customer complaint system. Develop executive quality metrics. Lead Quality Assurance personnel. Partner with Operations on quality improvement.

Requirements:

Required Qualifications Bachelor's degree in Engineering, Quality, or related field. 7-10+ years in medical device quality/regulatory leadership. Experience with

FDA, ISO

13485, and 510(k). Strong leadership and communication skills. Key Performance Indicators Audit results CAPA effectiveness Customer complaint trends Supplier quality QMS compliance