Senior Quality & Compliance Manager - Manufacturing

Medline Industries, Inc.; Norristown (Montgomery County); On-site; USD 134,000 - 201,000; Full time

Job summary

Medline Industries, LP seeks a quality and regulatory professional to manage quality and compliance for assigned department(s) and align plans with resource and operational needs. Responsibilities include ensuring compliance with QSR, GMP, ISO regulations, coordinating with divisions and suppliers, managing complaints, and driving continuous improvement projects to deliver high-quality products.

The role also involves assisting in design and validation activities, guiding the quality assurance

Qualifications

• Bachelor’s degree in Engineering, Science, or Technical Field or equivalent experience.
• At least 4 years of experience related to the design/operation of medical device or drug combination product platforms, design controls, and risk management with compliance to QSR/GMP/ISO requirements.

Responsibilities

• Ensure quality and regulatory compliance with applicable regulations (ex. QSR, GMP, ISO).
• Liaise with divisions, suppliers, manufacturing and operations to ensure quality products and customer satisfaction.
• Manage complaints and develop new approaches to solve problems identified during investigations.
• Identify and manage execution of continuous improvement projects and assist in product evaluation from QA/regulatory standpoint.
• Assist in planning design, testing, inspection, and process validations to assure quality products or components.
• Ensure all quality issues are resolved to customer satisfaction and interface with customers to resolve production quality issues.

Skills

Regulatory knowledge

Data analysis

Project coordination

Excel skills

Travel willingness

Education

Bachelor’s degree in Engineering, Science, or Technical Field

Job description

Medline Industries, LP seeks a quality and regulatory professional to manage quality and compliance for assigned department(s) and align plans with resource and operational needs. Responsibilities include ensuring compliance with QSR, GMP, ISO regulations, coordinating with divisions and suppliers, managing complaints, and driving continuous improvement projects to deliver high-quality products.

The role also involves assisting in design and validation activities, guiding the quality assurance