Manager.Quality.

Invacare; Elyria (OH); On-site; USD 110,000 - 150,000; Full time

Job summary

Invacare in Elyria, OH is seeking an experienced Quality Manager to lead the Quality Management System, drive continuous improvement, and ensure regulatory and customer satisfaction.

The role oversees quality control/assurance activities, CAPA, and interactions with FDA/ISO inspections, providing leadership to the quality team and partnering with production.

Qualifications

• Bachelor’s degree in Science or Engineering is required.
• Master’s degree is preferred.
• Minimum 5 years in medical device industry with supervisory experience.
• Strong communication, analytical, organization and management skills.

Responsibilities

• Oversee development, implementation, and maintenance of the QMS in compliance with FDA, ISO 13485:2016, and regulations.
• Oversee Design Quality Assurance activities across the product design process.
• Prepare and maintain monthly and quarterly Management Review records for both sites.
• Act as management representative for FDA and ISO 13485 inspections.
• Manage CAPA process for Invacare and Invamex, including investigation and effectiveness checks.
• Oversee process engineering projects and Quality Hold activities.
• Assist in closure of FDA Recall activities.
• Develop and maintain procedures for product inspection and testing.
• Implement corrective and preventive actions to address non-conformances.
• Oversee Quality Engineering for PPAPs.
• Collaborate with production to address quality concerns and actions.
• Maintain Training Matrix ensuring personnel are trained on quality standards.

Skills

Project management

Leadership

Communication

Analytical thinking

Quality systems

Education

Bachelor's degree in science or engineering

Master's degree preferred

Tools

MS Office

MS Project

Visio

Electronic document management (EDMS)

Job description

Job Details: Job Location: Elyria, OH 44035, Summary:

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.

Essential Functions:

• 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.

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

An Equal Opportunity/Affirmative Action Employer –M/F/Disabled/Vet