Quality Systems Engineer

Overview: The Quality Systems Engineer will oversee and improve quality management systems to ensure compliance with ISO 9001:2015. The primary focus will be managing corrective actions, deviations, and continual improvement initiatives. The ideal candidate will have a strong background in quality systems, excellent problem-solving skills, and the ability to collaborate across departments to achieve quality goals. Key Responsibilities: Corrective Actions: Lead investigations into nonconformities, customer complaints, and internal audit findings. Develop and implement effective corrective and preventive actions (CAPAs). Monitor the effectiveness of CAPAs and provide follow-up reporting. Deviations: Manage the review, approval, and tracking of process deviations. Collaborate with production, engineering, and other departments to resolve deviation issues. Ensure that deviations are documented and resolved in compliance with company and regulatory standards. Quality Management System (QMS): Maintain and improve the QMS to ensure continued compliance with ISO 9001:2015. Conduct internal audits and support external audits and certifications. Develop, update, and distribute QMS documentation, including procedures, work instructions, and forms. Continuous Improvement: Identify and implement opportunities for process improvements and operational efficiencies. Facilitate root cause analysis (RCA) sessions to address quality issues. Provide training and mentorship to employees on quality tools and practices. Collaboration: Work closely with production, engineering, and other teams to ensure alignment with quality objectives. Support cross-functional teams in meeting customer requirements and industry standards. Qualifications: Bachelor’s degree in Engineering, Quality Management, or a related field (or equivalent experience). Minimum of 3-5 years of experience in quality systems within a manufacturing environment, preferably machining. Proficiency in ISO 9001:2015 standards and requirements. Strong knowledge of root cause analysis, CAPA processes, and deviation management. Excellent analytical, organizational, and communication skills. Familiarity with statistical process control (SPC), lean manufacturing, and Six Sigma methodologies is a plus. Proficiency in quality software and tools (e.g., QMS platforms, Microsoft Office Suite). Job Type: Full-time Pay: $70,000.00 - $80,000.00 per year Benefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance Compensation Package: Bonus opportunities Ability to Commute: Columbia City, IN 46725 (Preferred) Ability to Relocate: Columbia City, IN 46725: Relocate before starting work (Preferred) Work Location: In person