Sustaining Quality Director: Strategy, Risk & Remediation

Medline Industries, Inc. in

Northfield Township (IL)

On-site

USD 177,000 - 266,000

Full time

5 days ago

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Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a senior leader to drive Sustaining Quality programs, ensuring compliance for commercial products and the Quality Management System. You will translate priorities into plans, guide remediation efforts, and align cross-functional activities to improve patient safety and product availability.

The role manages complex programs, oversees audits, and reports on remediation progress, CAPA effectiveness, and resource needs while building organizational capability for

Qualifications

Bachelor’s degree in Engineering, Science, Quality, Regulatory Affairs or related field.
At least 7 years in medical device or regulated industry with quality systems and CAPA experience.
At least 4 years of management experience.

Responsibilities

Develop and implement strategy for Sustaining Quality aligned with quality objectives and regulatory commitments.
Lead remediation and product lifecycle quality programs across functions.
Establish risk-based portfolio management and execution controls, monitor milestones and resources.
Act as liaison with senior leadership to drive alignment and decisions.

Skills

Quality systems

CAPA

Regulatory affairs

Risk management

Cross-functional leadership

Excel

Education

Bachelor's degree in Engineering/Science/Quality/Regulatory Affairs

Tools

Microsoft Excel

Job description

The role manages complex programs, oversees audits, and reports on remediation progress, CAPA effectiveness, and resource needs while building organizational capability for

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