Manager.Quality.

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.
• Manage Purchasing Controls and Supplier Quality functions, including supplier requirements, maintenance of the Approved Supplier List, execution of supplier audits, and follow-up on corrective actions.
• Prepare and maintain monthly and quarterly Management Review records for both sites and oversee corporate-level Management Review activities.
• Direct and execute Internal Audit programs for Invacare North American sites, including developing audit schedules, training and qualifying auditors, and reporting findings or areas for improvement to management.
• 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.
• Oversee the Document Control Department, serving as the Quality/Quality Systems approver for all Corporate Quality Management System (QMS) documents within the Invacare Corporate QMS.
• Manage the Training Department by developing and maintaining training plans, SOPs, work instructions, and technical documentation to meet functional goals in a compliant and efficient manner.
• Collaborate with Engineering, Supplier Quality, Plant Quality, and other functions to identify recurring issues and drive corrective actions and process improvements.
• Ensure all required training is identified, assigned, and completed by direct reports.
• Participate in internal and external audits, including FDA inspections, ensuring all product evaluation and escalation process documentation is accurate and audit-ready.
• Assess staffing needs, manage departmental budgets, and recruit, hire, or promote team members with the necessary skills and competencies to achieve superior results.
• Foster a collaborative team environment that values diversity, leverages individual strengths, and promotes innovation.
• 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.

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