Strategic QA Director, Medical Devices & Compliance

Medline Industries, LP; Northfield (MN); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Life and disability insurance

Job summary

Medline Industries, LP seeks a senior quality leader to guide the Quality team(s) in ensuring quality and compliance for medical device/drug combination products. You will translate long-term goals into strategic plans and drive execution across departments.

Responsibilities include developing product specifications, collaborating with suppliers and divisions, and overseeing audits to maintain QSR/GMP/ISO compliance. Travel up to 30% is required.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• 7+ years of experience in design/operation of medical device or drug combination product platforms, design controls, risk management.
• 4+ years of management experience.
• Knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.

Responsibilities

• Direct the development of product specifications for Medline branded products.
• Partner with Supplier Audit department and Division to determine optimal Supplier relationship.
• Develop and implement strategy for the Quality department(s) based upon Quarterly Management Review.
• Prepare and deliver Customer presentations.
• Act as liaison with Senior Leadership of Divisions, Suppliers, Manufacturing, and/or Operations to ensure quality products, on time delivery, and customer satisfaction.

Skills

Excel proficiency

Data analysis

Strategic planning

Leadership

Budget management

Education

Bachelor’s degree in Engineering/Science/Technical

Tools

Microsoft Excel

Job description

Medline Industries, LP seeks a senior quality leader to guide the Quality team(s) in ensuring quality and compliance for medical device/drug combination products. You will translate long-term goals into strategic plans and drive execution across departments.

Responsibilities include developing product specifications, collaborating with suppliers and divisions, and overseeing audits to maintain QSR/GMP/ISO compliance. Travel up to 30% is required.