Site Quality Assurance Engineer II

ZOLL Medical Corporation•Deerfield, WI

4d•$97,000 - $120,000•Hybrid

About The Position

The Site Quality Assurance Engineer II provides technical support for manufacturing and operational quality activities, focusing on investigations, process improvement, and quality system effectiveness. The role leads manufacturing quality investigations and works with Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams to improve process performance, product quality, and compliance with regulatory and company standards. The position supports material review and nonconforming material resolution; manufacturing CAPA and nonconformance investigations; analysis of yield, scrap, rework, and process capability data; manufacturing process validation; equipment qualification; and new product introduction readiness. It also contributes to audits, inspection readiness, regulatory compliance, documentation, and continuous improvement initiatives. This is a hybrid role requiring regular presence at a manufacturing or operational facility, with occasional travel for training, audits, investigations, or multi-site support. The annual salary range is $97,000 to $120,000, and the position is eligible for an annual bonus under the company bonus plan.

Requirements

Bachelor's degree in Engineering or a related technical discipline.
At least 5 years of experience in quality engineering, manufacturing quality, or a related engineering role.
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, including the ability to present findings and recommendations to technical stakeholders.
Ability to work effectively in a hybrid or on-site environment and collaborate 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.

Nice To Haves

Experience in the medical device industry.
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.

Responsibilities

Lead investigations into manufacturing and process quality issues, including root cause analysis, data review, and recommendations.
Support Material Review Board activities and nonconforming material resolution, including documentation, disposition support, and cross-functional coordination.
Lead manufacturing CAPA and nonconformance investigations, including documentation, coordination, and corrective-action follow-up.
Analyze yield, scrap, rework, and process capability data to identify trends, recurring issues, and improvement opportunities.
Support manufacturing process validation, equipment qualification, and new product introduction readiness through documentation review and participation in quality assessments.
Collaborate with Manufacturing, Operations, Engineering, Supply Chain, Supplier Quality, and Regulatory teams to resolve site quality issues and implement solutions.
Participate in internal and external audits, inspection readiness activities, and regulatory compliance efforts.
Ensure site quality activities comply with applicable regulatory requirements, quality system standards, and internal procedures.
Maintain clear, accurate, and timely investigation, analysis, and quality records.
Contribute to continuous improvement initiatives related to manufacturing quality, process performance, and quality system effectiveness.