Pharma Quality Lead — Contamination Control Strategy

Medline

Northfield Township (IL)

On-site

USD 116,000 - 174,000

Full time

33 hours ago
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Benefits offered by this job

Health insurance
401(k) contributions
Paid time off
Diversity & Belonging

Job summary

Medline Industries, LP is seeking a seasoned quality leader to oversee major quality projects and strengthen our global quality system. You will collaborate across the organization and with external partners to ensure compliance with applicable regulations and standards, guiding corrective actions and process improvements.

You will contribute to contamination control strategies, environmental monitoring programs, and robust risk management while supporting audits and continuous improvement

Qualifications

  • Bachelor's degree in engineering or related science.
  • 7+ years of experience in pharmaceutical manufacturing and/or medical device quality.
  • Willingness to travel up to 30% for business purposes (domestic and international).

Responsibilities

  • Lead quality projects across the organization and train affected groups on process changes.
  • Identify and drive opportunities to improve the QMS for compliance and efficiency.
  • Lead root cause investigations and plan corrective/preventive actions with evidence.
  • Evaluate Cost of Quality and propose/execute approved cost-saving projects.
  • Provide process guidance to manufacturing and corporate functions across sites.
  • Lead contamination control, environmental monitoring, and related validation efforts.
  • Support audits, inspections, and remediation as a subject matter expert.

Skills

Project leadership
Quality systems
Risk management
Root cause analysis
Auditing & compliance

Education

Bachelor's degree in mechanical engineering, biomedical engineering, electrical engineering, software engineering, or related science

Job description

Medline Industries, LP is seeking a seasoned quality leader to oversee major quality projects and strengthen our global quality system. You will collaborate across the organization and with external partners to ensure compliance with applicable regulations and standards, guiding corrective actions and process improvements.

You will contribute to contamination control strategies, environmental monitoring programs, and robust risk management while supporting audits and continuous improvement

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