Quality Engineer (Deerfield)

Quality Assurance Specialist

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 Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. 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 careerand a purpose. Join our team. It's a great time to be a part of ZOLL!

Job Summary

Performs a variety of complex tasks related to Quality Assurance including, but not limited to : performing trend analyses on quality data to provide early warning of potential problems and improvement opportunities. Develop, implement, and manage value improvement projects which incorporate a Lean / Six-Sigma approach. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities including non-product software.

Essential Functions

• Performs internal quality audits and effectiveness reviews (FDA's QSR, ISO 13485, MDD, CMDR). Conducts supplier evaluations and audits.
• Responsible for the development and execution of Lean / six-Sigma and other cost improvement initiatives that can be related to product quality.
• Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance.
• Responsible to build and improve key business relationships within the organization's cross functional departments.
• Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications.
• Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented.
• Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses.
• Prepare, submit and coordinate the process validation requirements for non-product software validations.
• Participates in the FDA premarket approval process (PMA) for new and modified medical devices.
• Participates in the nonconforming material / Material Review Board process. Championing the implementation of Lean Manufacturing processes.
• Participate in Kaizen events as a representative of the quality department.

Required / Preferred Education and Experience

Knowledge, Skills and Abilities

Physical Demands

Working Conditions

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's 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.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.