Senior Quality Engineer: QMS & Contamination Control

Regulatory Jobs; Northfield Township (IL); On-site; USD 116,000 - 174,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a seasoned Quality leader to oversee and advance quality projects across the organization. You will collaborate with cross-functional teams, act as a subject matter expert on regulatory standards, and support strategic initiatives to improve the global quality system and manage emergency challenges.

You will bridge design and manufacturing, ensuring cost-effective production of high-quality products, while driving risk-based decision making and continuous

Qualifications

• Experience leading quality projects across pharma/medical devices.
• Strong knowledge of quality management systems and regulatory expectations.
• Ability to drive CAPA and risk-based decision making.
• Familiarity with audits, inspections, and remediation activities.

Responsibilities

• Lead quality initiatives across the organization and present outcomes to leadership.
• Identify opportunities to improve QMS efficiency and compliance.
• Lead root cause analysis and drive corrective/preventive actions with documentation.
• Evaluate Cost of Quality and drive cost-saving projects.
• Provide process guidance across manufacturing and corporate functions.
• Apply risk management tools (e.g., FMEA) to mitigate risks and document actions.
• Contribute to the CCS and drive continuous improvement.
• Develop best practices for environmental monitoring, gowning, cleaning, and cleanroom operations.
• Provide training and technical leadership from shop floor to executives.
• Lead investigations related to contamination and product quality events.
• Serve as SME during audits and remediation efforts.

Skills

QMS leadership

Cross-functional leadership

Project management

Regulatory compliance

Risk management

FMEA

Education

Bachelor's degree in engineering

Job description

Medline Industries, LP is seeking a seasoned Quality leader to oversee and advance quality projects across the organization. You will collaborate with cross-functional teams, act as a subject matter expert on regulatory standards, and support strategic initiatives to improve the global quality system and manage emergency challenges.

You will bridge design and manufacturing, ensuring cost-effective production of high-quality products, while driving risk-based decision making and continuous