Quality Assurance Manager

Company Description

Invacare America, headquartered in Elyria, Ohio, is a global leader in the manufacture and distribution of home and long-term care medical products. Since 1885, Invacare has been dedicated to helping people with disabilities lead active, independent lives. The company provides innovative medical solutions through home medical equipment providers, retail and e-commerce channels, residential care operators, distributors, and government health services.

Role Description

This is a full-time, on-site role located in Elyria, OH, for a Quality Assurance 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.

Qualifications

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 for both Invacare and Invamex, 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.

Interested candidates are encouraged to apply. You can email your resume to ***email_hidden***