Senior Quality Engineer

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 career-and a purpose.

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

Job Type

On Site

Job Summary

The Senior Quality Engineer will play a key role in the Quality function in support of Engineering and Production. This includes but is not limited to, the development and continuous improvement of Quality Management System processes and documentation, providing design and development/sustaining support through Quality and Regulatory planning, management and execution of plans, complaint handling, root cause analysis, and quality auditing, both internal and external.

Essential Functions

• Contribute as a core team member of product development teams, representing the Quality Assurance function in activities such as Design FMEAs and risk analysis.
• Develop quality inspection procedures, including sampling plans, for production components and finished devices. Supports Incoming Quality Control inspection in the performance of quality inspection and testing, including the development of inspection fixtures.
• Support the supplier selection and qualification process with supplier audits, as well as Supplier Corrective Action Reports.
• Contribute to process validation, design verification, and design validation. Provide input regarding appropriate statistical methods, test methodologies, test facilities, and test equipment.
• Develop and maintain Quality Plans throughout the product life cycle beginning with project inception/initiation.
• Investigate nonconforming materials and provide input to Material Review Board activities.
• Coordinate sterilization validation, packaging validation, and biocompatibility testing.
• Assist in the complaint and failure investigation process, as needed.
• Conduct internal audits, as assigned.
• Maintain and comply with ZOLL SOP's. Review procedures to ensure adequacy for device development to conform to business and Quality Management System requirements.

Required/Preferred Education and Experience

• Bachelor's Degree Engineering or related field required
• 4-6 years Experience in a medical device design, manufacturing, or quality engineering environment. Preferable experience includes capital equipment and disposable (catheter) development and manufacturing. preferred
• Experience using Microsoft Word, Excel

Knowledge, Skills and Abilities

• Demonstrated technical skills in the development and manufacturing of medical devices.
• Good communication skills, both written and oral, and must be computer literate.
• Knowledge of and experience in developing and manufacturing medical devices in conformance with FDA Quality System Regulation and ISO 13485:2003 requirements.
• Knowledge of analytical tools and methods related to design, development, and manufacturing, including statistics, DOE, and the use of computer/software packages.
• Understanding of continuous improvement methodologies including Lean and Six Sigma.
• Must possess a high sense of urgency, initiative, and common sense.
• Must present a professional demeanor and demonstrate an ability to work effectively with a diverse group of individuals.
• Must be energetic, and work quickly and efficiently with detail and accuracy.

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.

• 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.

The pay range for this position is $134,000 - $168,000 per year. The compensation may vary outside of this range depending on geographic location, work experience, education, and skill level.

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.