Principal Quality Assurance Engineer
ZOLL Medical Corporation
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!
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.
Lead multi-discipline product quality teams for investigations and continuous improvement.
Develop and implement quality improvement programs.
Investigate causes of quality and yield problems identified in the field and throughout the manufacturing processes.
Interface with other departments as necessary to provide assistance in CAPA execution.
Collect, analyze and disseminate quality data throughout the organization using statistics to identify trends.
Participate in Change Control and Material Review Board review activities.
Represent QA in multi-discipline New Product Introduction teams.
Ensure that all work activity is performed in accordance with established internal procedures, ISO and FDA's Quality System Requirements.
Plan and conduct internal process audits and support supplier quality audits.
Facilitate UL/ETL/TUV safety audits and support 3rd party external audits.
Provide support Health Risk Assessments by collecting supporting information and executing risk assessments.
Support and mentor Quality Assurance Engineers.
Training in Quality Problem Solving tools and Statistical Analysis
Excellent written, verbal, and interpersonal communication skills.
Experience with product design verification/validation, reliability, and manufacturing tools validation techniques.
Experience with mechanical and electronic test equipment.
Experience with ISO 13485, ISO 14971, FDA QSR, MDD and MDR.
Ability to travel up to 20%, domestic and international, for customer investigations and escalations.
Required/Preferred Education and Experience:
Four-year Engineering degree, Masters Engineering degree preferred
Minimum 5 years related experience in a regulated environment, preferably medical device
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.
Standing - Occasionally
Walking - Occasionally
Sitting - Constantly
Talking - Occasionally
Hearing - 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.