Manufacturing Quality Director — Drive Compliance

Jobiqo; North Mankato (MN); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Minnesota is seeking a Senior Quality Director to provide leadership and direction to Quality teams, shaping strategy and guiding the execution of long-term goals across assigned departments.

You will oversee product quality, ensure FDA/ISO compliance, collaborate with suppliers, manufacturing, and product managers, and drive continuous improvement through data-driven decision making and strategic budgeting.

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field.
• At least 7 years of experience related to the design/operation of medical device or drug combination product platforms.
• At least 4 years of management experience.
• Extensive knowledge of 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.

Responsibilities

• Direct the development of product specifications for Medline branded products and testing requirements.
• Partner with Supplier Audit department and Division to determine optimal supplier relationships.
• Develop and implement QA strategy and oversee QSR compliance across departments.
• Lead budgeting, hiring, and staff development for QA teams.
• Coordinate with senior leadership and cross-functional teams to ensure timely delivery of quality products.

Skills

Quality leadership

Regulatory compliance (FDA/ISO)

Quality systems

Data analysis

Education

Bachelor’s degree in Engineering/Science/Technical Field

Tools

Microsoft Excel

Job description

Medline Industries, LP in Minnesota is seeking a Senior Quality Director to provide leadership and direction to Quality teams, shaping strategy and guiding the execution of long-term goals across assigned departments.

You will oversee product quality, ensure FDA/ISO compliance, collaborate with suppliers, manufacturing, and product managers, and drive continuous improvement through data-driven decision making and strategic budgeting.