Quality Systems Engineer

Job description

Job DetailsJob Location: PPC - Pleasant Prairie - Pleasant Prairie, WI 53158Position Type: Full TimeThe Quality Systems Engineer is responsible for maintaining, enhancing, and ensuring the effectiveness of the Quality Management System (QMS) in compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820. This role plays a key part in supporting internal and external audits, overseeing document control and CAPA processes, and driving continuous improvement initiatives across the organization. The engineer will collaborate with cross-functional teams to identify and implement quality system improvements, ensuring alignment with regulatory requirements and industry standards. With a strong focus on compliance, process optimization, and risk mitigation, this position is critical in supporting the company’s goal of delivering high-quality products while maintaining a culture of operational excellence and regulatory readiness. Act as a role model and ensure safety is built into our QMS and work processes. Develop, implement, and maintain Quality Management System (QMS) processes to ensure compliance with FSSC 22000, ISO 9001, ISO 13485, and 21 CFR Part 820. Ensure compliance wit...