This individual will support the Operations Organization and Post Market Surveillance Organizations with quality improvement and corrective/preventative action programs with other departments in a cross functional environment.  Individual will be a self-starter and decision-maker.

• Lead multi-discipline product quality teams and participate in New Product Introduction projects.
• Develop and implement quality improvement
• Ability to lead product quality investigations to a successful conclusion.
• Investigate causes of quality and yield problems identified in Incoming Inspection, Manufacturing processes and Final QA
• Interface with other departments as necessary to provide assistance in CAPA execution.
• Collect, analyze and disseminate quality data throughout the
• Participate in Change Control Review and Material Review Board activities.
• Ensure that all work activity is performed in accordance with established internal procedures, ISO and FDA's Quality System
• Coordinate departmental functions with those performed in other departments to ensure smooth workflow and timely completion of
• Plan and conduct internal process audits, support supplier audits, and facilitate UL/ETL/TUV factory audits.
• Execute risk assessments, collect supporting information and provide recommendations for executive management consideration.
• Provide support in product investigations.

• Minimum 5 years related experience in a regulated environment, preferably medical device
• Excellent written, verbal, time management and interpersonal communications skills
• ASQ Certified Quality Engineer desirable
• Familiar with mechanical and electronic test equipment
• Familiar with Statistical Analysis to analyze data and identify trends
• Experience with ISO 9001, ISO 13485, 15014971 and FDA QSR for Medical Devices
• Proficient with MS Office and familiar with Oracle, Agile and Minitab
• Ability to travel up to 20%, domestic and international, for customer investigations and escalations

Education:

• Four year engineering degree

 ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Oppotunity Employer M/F/D/V.