Director of Quality Assurance & Regulatory Affairs

Mac Medical Inc

Millstadt, IL

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

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Vacancy posted 5 days ago

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