Introduction

The Medical Devices quality manager (MDQM) performs the necessary review tasks for medical device products prior to release and provides the appropriate feedback to ensure safe use. Typically, the MDQM is responsible for overseeing various aspects of the product's design, manufacturing, testing, packaging and labelling requirements. In addition, the MDQM may be involved in clinical trials, clinical monitoring and/or post-market surveillance activities for medical devices.

Job Responsibilities

• Ensure medical device compliance with FDA regulations and applicable ISO standards
• Review the technical documentation for completeness, accuracy, adherence to regulatory requirements, and completeness of information provided
• Provide input to design specifications, engineering drawings and other documents
• Develop test plans and procedures
• Perform inspections and audits of facilities
• Work closely with FDA and manufacturers to assure that the right people understand what they need to do before releasing the device to market

Maintain close contact with FDA field offices and laboratories to ensure proper communication between them and the manufacturer

Education Requirements

Bachelor's degree in a scientific discipline related to the medical device industry OR 10 years of work experience in a similar role that requires extensive knowledge and understanding of FDA regulations and ISO standards and 5 years experience working with FDA