Senior Quality Engineer: QMS & Compliance

Medline Industries, Inc.; Northfield (MN); On-site; USD 116,000 - 174,000; Full time

Job summary

Medline Industries, LP is seeking a senior quality program leader to drive global quality initiatives. You will manage projects across the quality organization, collaborate with cross-functional teams, and act as SME to ensure regulatory compliance.

This role bridges design and manufacturing to enable cost-effective production of high-quality products. Ideal candidates bring 7+ years in pharma/manufacturing quality, strong leadership, and deep knowledge of QMS, FDA/cGMP standards, and risk

Qualifications

• Bachelor's degree in an engineering field
• 7+ years in pharmaceutical manufacturing or medical device quality
• Travel up to 30% of the time
• Experience with Quality Management System (QMS) and regulatory compliance
• Strong leadership and communication capabilities

Responsibilities

• Lead quality projects across the organization and present deliverables to leadership.
• Identify and drive improvements to the QMS and compliance.
• Lead root-cause investigations and plan corrective/preventive actions (CAPAs).
• Evaluate Cost of Quality and implement cost-saving projects.
• Coordinate risk management and maintain documentation across sites.

Skills

Leadership

Cross-functional collaboration

Project management

Regulatory knowledge

Quality systems

Critical thinking

Communication

Education

Bachelor's degree in mechanical engineering

Bachelor's degree in biomedical engineering

Bachelor's degree in electrical engineering

Bachelor's degree in software engineering

Related science

Job description

Medline Industries, LP is seeking a senior quality program leader to drive global quality initiatives. You will manage projects across the quality organization, collaborate with cross-functional teams, and act as SME to ensure regulatory compliance.

This role bridges design and manufacturing to enable cost-effective production of high-quality products. Ideal candidates bring 7+ years in pharma/manufacturing quality, strong leadership, and deep knowledge of QMS, FDA/cGMP standards, and risk