Job Description

Our client, a leading manufacturer of durable medical equipment, is seeking a motivated, experienced and FDA experienced Quality Manager.

The Quality Manager is responsible for leading and managing all aspects of the Quality Management System (QMS) to ensure compliance with regulatory requirements, industry standards, and company policies.

This role drives continuous improvement, oversees quality control and assurance activities, and provides leadership to the quality team to support operational excellence and customer satisfaction.

Responsibilities:

• Oversee the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with FDA, ISO 13485:2016, and other applicable regulations.
• Oversee Design Quality Assurance activities, ensuring consistent and effective quality input throughout the design process for Invacare products.
• Prepare and maintain monthly and quarterly Management Review records for both sites and oversee corporate-level Management Review activities.
• Acting as the management representative for FDA and ISO 13485 inspections
• Manage and administer the CAPA process, ensuring timely initiation, tracking, investigation, root cause analysis, implementation of actions, and verification of effectiveness
• Overseeing process engineering projects.
• Oversee Quality Hold activities at OHIO.
• Assist in closure of FDA Recall activities.
• Developing and maintaining procedures for product inspection and testing
• Developing and implementing corrective and preventive actions to address non-conformances.
• Oversee Quality Engineering function for completion of PPAPs.
• Works with production in addressing quality concerns, providing recommendations, and establishing/monitoring corrective actions.
• Maintaining Training Matrix and ensuring that required personnel are trained on quality standards and procedures.
• Demonstrate flexibility, creativity, and a proactive approach to taking on new responsibilities as needed.
• Provide quality leadership to support continuous improvement of the Quality Management System.
• Other duties may be assigned as needed.

Qualifications:

• Bachelor’s Degree in Science or Engineering; Master Degree Preferred
• Minimum 5 years of experience working in a medical device industry with some supervisory experience.
• Experience managing projects and directing and leading the team members.
• Strong communication, analytical, organization and management skills
• Proficiency with MS Office, MS Project, Visio, electronic document management
• Knowledge of 21CFR 820 (QSR) and ISO 13485
• Experience with FDA audits desirable
• High ethical standards and integrity

Location: Elyria OH
Salary: $120K