Site Quality Assurance Engineer II

Acute Care TechnologySite Quality Assurance Engineer II (On-Site/Hybrid) – P3Job Summary The Site Quality Assurance Engineer II provides technical support for manufacturing and operational quality activities, with a focus on investigations, process improvement, and quality system effectiveness. This role leads manufacturing quality investigations, partners with Manufacturing, Operations, Engineering, Supply Chain, and Regulatory teams, and drives actions that improve process performance, product quality, and compliance with regulatory and company standards.Essential Responsibilities• Lead investigations into manufacturing and process quality issues, including root cause analysis, data review, and development of recommendations to address quality concerns.• Support Material Review Board activities and nonconforming material resolution, including documentation, disposition support, and coordination with cross-functional teams.• Lead manufacturing CAPA and nonconformance investigations, including documentation, cross-functional coordination, and follow-up of corrective actions.• Analyze yield, scrap, rework, and process capability data to identify trends, recurring issues, and opportunities for manufacturing quality improvement.• Support manufacturing process validation, equipment qualification, and new product introduction readiness activities through review of documentation and participation in related quality assessments.• Collaborate with Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams to resolve site quality issues and implement effective solutions.• Participate in internal and external audits, inspection readiness activities, and regulatory compliance efforts to support adherence to applicable quality system requirements and internal procedures.• Ensure site quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures.• Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.• Contribute to continuous improvement initiatives related to manufacturing quality, process performance, and quality system effectiveness.Required Qualifications• Bachelor’s degree in Engineering or a related technical discipline.• 5 plus years of experience in quality engineering, manufacturing quality, or a related engineering role, preferably in the medical device industry.• Demonstrated experience leading investigations, root cause analysis, and manufacturing quality improvement activities.• Working knowledge of manufacturing quality systems, nonconformance management, and CAPA processes.• Knowledge of statistical process control, process capability analysis, and data-driven problem solving.• Experience collaborating in cross-functional environments to resolve technical and quality issues.• Strong written and verbal communication skills, with the ability to clearly present findings and recommendations to technical stakeholders.• Ability to work effectively in a hybrid or on-site environment while collaborating across cross-functional teams.Preferred Qualifications• Experience in medical device manufacturing, process validation, equipment qualification, and new product introduction support.• Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements.• Experience supporting MRB activities, nonconformance systems, and manufacturing CAPA investigations.• Knowledge of statistical analysis tools and manufacturing quality methodologies.• ASQ Certified Quality Engineer or similar certification is a plus.Work Environment• Hybrid or on-site role with regular presence at a manufacturing or operational facility and occasional travel as needed for training, audits, investigations, or multi-site support.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 TypeHybridJob SummaryThe Site Quality Assurance Engineer II provides technical support for manufacturing and operational quality activities, with a focus on investigations, process improvement, and quality system effectiveness. This role leads manufacturing quality investigations, partners with Manufacturing, Operations, Engineering, Supply Chain, and Regulatory teams, and drives actions that improve process performance, product quality, and compliance with regulatory and company standards.Essential FunctionsLead investigations into manufacturing and process quality issues, including root cause analysis, data review, and development of recommendations to address quality concerns.Support Material Review Board activities and nonconforming material resolution, including documentation, disposition support, and coordination with cross-functional teams.Lead manufacturing CAPA and nonconformance investigations, including documentation, cross-functional coordination, and follow-up of corrective actions.Analyze yield, scrap, rework, and process capability data to identify trends, recurring issues, and opportunities for manufacturing quality improvement.Support manufacturing process validation, equipment qualification, and new product introduction readiness activities through review of documentation and participation in related quality assessments.Collaborate with Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams to resolve site quality issues and implement effective solutions.Participate in internal and external audits, inspection readiness activities, and regulatory compliance efforts to support adherence to applicable quality system requirements and internal procedures.Ensure site quality activities are performed in compliance with applicable regulatory requirements, quality system standards, and internal procedures.Maintain clear, accurate, and timely documentation of investigations, analyses, and quality records.Contribute to continuous improvement initiatives related to manufacturing quality, process performance, and quality system effectiveness.Required/Preferred Education and ExperienceBachelor's Degree in Engineering or a related technical discipline 5+ years of experience in quality engineering, manufacturing quality, or a related engineering role, preferably in the medical device industry Experience collaborating in cross-functional environments to resolve technical and quality issues Experience in medical device manufacturing, process validation, equipment qualification, and new product introduction support Experience supporting MRB activities, nonconformance systems, and manufacturing CAPA investigations ASQ Certified Quality Engineer or similar certification is a plus Knowledge, Skills and AbilitiesDemonstrated experience leading investigations, root cause analysis, and manufacturing quality improvement activities. Working knowledge of manufacturing quality systems, nonconformance management, and CAPA processes. Knowledge of statistical process control, process capability analysis, and data-driven problem solving. Strong written and verbal communication skills, with the ability to clearly present findings and recommendations to technical stakeholders. Ability to work effectively in a hybrid or on-site environment while collaborating across cross-functional teams. Familiarity with FDA Quality System requirements, ISO 13485, and medical device regulatory requirements. Knowledge of statistical analysis tools and manufacturing quality methodologies Preferred LanguagesEnglish - AdvancedTravel Requirements Hybrid or on-site role with regular presence at a manufacturing or operational facility and occasional travel as needed for training, audits, investigations, or multi-site supportPhysical DemandsThe 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 annual salary for this position is:$97,000.00 to $120,000.00This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at . Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee’s primary work location.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.SummaryLocation: US WI DeerfieldType: Full time