Senior Quality Assurance Engineer

Acute Care Technology

Job Summary:
This position is responsible for supporting electrode product and process sustaining activities through the application of Quality engineering skills for medical devices. Focuses on process, equipment, and design verification and validations; working with teams to develop manufacturing and quality processes and define their related tools; troubleshooting and support of manufacturing floor and field issues, and review and approve validations.

Essential Job Functions:
• Review and approve verification and validation protocols and reports
• Participate in Change Control review and approval activities as required
• Provide technical guidance and oversight to Quality Engineers
• Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971
• Develop and implement quality plans
• Ensures post market surveillance reviews are conducted and reports documented according to schedule
• Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues.
• Provide key quality trending information and data for Management Review and monthly KPI review, as applicable
• Represent quality interests and concerns on project teams
• Investigate causes of quality and yield problems identified in the field and throughout the manufacturing and testing processes
• Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as process validation, equipment, test methods, root cause analysis, risk mitigation, process improvement tools, sampling plans, etc.
• Provide support during regulatory audits and responses to government agency questionsAt 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

This position is responsible for supporting electrode product and process sustaining activities through the application of Quality engineering skills for medical devices. Focuses on process, equipment, and design verification and validations; working with teams to develop manufacturing and quality processes and define their related tools; troubleshooting and support of manufacturing floor and field issues, and review and approve validations.

Essential Functions

• Review and approve verification and validation protocols and reports.
• Participate in Change Control review and approval activities as required.
• Provide technical guidance and oversight to Quality Engineers.
• Participate in Risk Management process, including the development and maintenance of risk management files, ensuring compliance with ISO 14971.
• Develop and implement quality plans.
• Ensure post market surveillance reviews are conducted and reports documented according to schedule.
• Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues.
• Provide key quality trending information and data for Management Review and monthly KPI review, as applicable.
• Represent quality interests and concerns on project teams.
• Investigate causes of quality and yield problems identified in the field and throughout the manufacturing and testing processes.
• Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as process validation, equipment, test methods, root cause analysis, risk mitigation, process improvement tools, sampling plans, etc.
• Provide support during regulatory audits and responses to government agency questions.

Required/Preferred Education and Experience

• Bachelor's Degree in Engineering or technical discipline required
• 5 Years medical device experience requi