Quality Auditor - Medical Devices

Invacare Corporation (NYSE: IVC), headquartered in Elyria, Ohio, is the global leader in the manufacture and distribution of innovative home and long-term care medical products that promote recovery and active lifestyles. The company has 6,100 associates and markets its products in 80 countries around the world. For more information about the company and its products, visit Invacare?s website at www.invacare.com.

 

Invacare is seeking an experienced Quality Systems Auditor with at least two years in the medical device industry to conduct audits at our North American facilities and oversee the corrective action system. Thorough knowledge of FDA requirements, ISO 13485, excellent communication skills and a willingness to travel required. Must be able to work independently and conduct training. Bachelor?s degree with two years auditing experience or Associates degree with four years of auditing experience required.

 

JOB RESPONSIBILITIES:Establish, maintain and implement Corporate FDA/QSR audit program for all Invacare North American facilities, and other locations that distribute product in North America.Develop and maintain corporate audit schedule, to ensure compliance with FDA/ISO.Conduct QSR audits at all North American manufacturing facilities, and other locations that distribute product in North America, including Corporate Functional Departments. Prepare written reports of audit results complete with recommendations for corrective action and improvement where needed. Consults with facility management teams on problem solving and solution implementation. Solicit corrective action responses to nonconformance discovered during system audits. Ensure that corrective action is taken, where indicated, and conduct follow up audits to verify effectiveness. Manage corrective action process for corporate functional departments.Interface with all Invacare facility quality managers and functional departments to ensure that quality systems and procedures conform to Invacare corporate policies and ISO/QSR requirements. Ensure that facility systems? manuals appropriately reference the corporate functional systems documentation.Conduct training in Quality System procedures, compliance practices and related topics.Participate in Kaizen events and other projects aimed at investigating problems and improving compliance and quality.Initiate or assist with implementation of corrective and preventive actions.Special projects and other duties as required by supervisors.

 

QUALIFICATIONSBachelor?s degree with at least two years quality system auditing experience or two year degree with at least four years quality system auditing experience.Three to five years experience in Quality Assurance and analysis required.Thorough knowledge of ISO/ FDA requirements.Previous quality system auditing experience is essential, preferably in an FDA-regulated industry.Manufacturing operations experience in process controls and lean manufacturing is highly desirableExcellent written and oral communication skills.Ability and willingness to travel up to 25%.Ability to do public presentations and conduct effective training.Must be organized self-starter.

 

You'll work in a campus-like setting in Elyria, OH, convenient to Cleveland. We offer a competitive salary and benefits program including medical, dental, vision, life, disability, 401(k) retirement savings plan and education assistance. Invacare has a strong commitment to diversity and welcomes applications from all individuals. EOE M/F/D/V.