Head of Quality & Lab Diagnostics – Strategy & Compliance

Medline Industries, LP; United States; Sur place; USD 154 000 - 231 000; Plein temps

Avantages offerts par ce poste

Health insurance

Paid time off

401(k) contributions

Résumé du poste

Medline Industries, LP is seeking a senior Quality executive to lead Quality teams, set strategy, and drive long-term goals across assigned departments. Responsibilities include directing product specifications, supplier relationships, and QA program development to ensure quality, on-time delivery, and customer satisfaction.

The role requires extensive knowledge of regulatory standards and management experience, with travel up to 30% for business purposes.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 7+ years of experience in medical device/drug product design, quality or compliance.
• 4+ years of management experience.
• Knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, MDR.
• Advanced Excel and data analysis skills.

Responsabilités

• Direct development of product specifications for Medline branded products.
• Partner with Supplier Audit and Division to optimize supplier relationships.
• Develop and implement QA strategy; lead quarterly management reviews and customer presentations.
• Serve as liaison with senior leadership across divisions, suppliers, manufacturing and operations.
• Collaborate with suppliers and product managers on QA programs.
• Oversee QSR compliance and audits; manage staffing and budgets.

Connaissances

Regulatory standards

Quality systems

Data analysis

Project management

Excel skills

Team leadership

FDA compliance

Formation

Bachelor's degree

Description du poste

Medline Industries, LP is seeking a senior Quality executive to lead Quality teams, set strategy, and drive long-term goals across assigned departments. Responsibilities include directing product specifications, supplier relationships, and QA program development to ensure quality, on-time delivery, and customer satisfaction.

The role requires extensive knowledge of regulatory standards and management experience, with travel up to 30% for business purposes.