Support implementation and maintenance of quality systems compliant with ISO 13485 and FDA regulations
Evaluate and improve production processes to reduce inefficiencies, waste, and variation
Assist in New Product Development (NPD) activities, including documentation such as FMEAs, PPAPs, and Validations
Define material and product specifications in alignment with customer and regulatory requirements
Analyze quality data to identify trends and recommend process improvements
Support regulatory and compliance documentation, including ISO certifications, CA Prop 65, EU REACH, and RoHS
Participate in internal audits and assist with customer audits
Collaborate with cross-functional teams to support smooth product launches and quality goals
Maintain documentation and records using electronic Quality Management Systems
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Quality Specialist 2Nd Shift • Menomonee Falls, WI, United States
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