At ZOLL, we're passionate about improving patient outcomes and helping save lives.

We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

The Resuscitation division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won’t just have a job. You’ll have a career—and a purpose.

Join our team. It’s a great time to be a part of ZOLL!

Job Summary

This individual will support the Operations Organization and the Post Market Surveillance group with quality improvement and corrective/preventative action programs. Interface with R&D to support New Product Introductions in a cross functional environment.

Essential Functions

• Ensure that all work activity is performed in accordance with established internal procedures, ISO and FDA's Quality System Requirements.
• Collect, analyze and disseminate quality data throughout the organization using statistics to identify trends.
• Participate in Change Control and Material Review Board review activities.
• Develop and implement quality improvement programs.
• Lead multi-discipline product quality teams for investigations and continuous improvement.
• Represent QA in multi-discipline New Product Introduction teams.
• Plan and conduct internal process audits and support supplier quality audits.
• Potentially supervise and mentor 1 – 5 Quality Assurance Engineers.
• Investigate causes of quality and yield problems identified in the field and throughout the manufacturing processes.
• Provide support Health Risk Assessments by collecting supporting information and executing risk assessments.
• Facilitate UL/ETL/TUV safety audits and support 3rd party external audits.
• Interface with other departments as necessary to provide assistance in CAPA execution.

Required/Preferred Education and Experience

• Experience with mechanical and electronic test equipment.
• Experience with product design verification/validation, reliability, and manufacturing tools validation techniques.
• Bachelor's Degree Engineering required
• Experience with ISO 13485, ISO 14971, FDA QSR, MDD and MDR.
• Master's Degree Engineering preferred

Knowledge, Skills and Abilities

• Training in Quality Problem Solving tools and Statistical Analysis
• Ability to travel up to 20%, domestic and international, for customer investigations and escalations.
• Excellent written, verbal, and interpersonal communication skills.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Standing - Occasionally
• Repetitive Motions - Frequently

ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.