Senior Quality Systems Engineer – ISO 9001 & IATF 16949

Morales Professional, a morales group company; Lafayette (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Morales Professional is seeking a seasoned Quality Systems Engineer to lead and improve the QMS at our Fort Wayne, IN facility. You will maintain ISO 9001 and IATF 16949 compliance, drive internal and supplier audits, and manage document control and CAPA processes.

Collaborate with engineering, operations, and customers to strengthen quality performance, apply FMEA and Control Plans, and support PPAP/APQP activities while mentoring teams on best practices.

Qualifications

• 5+ years of experience in a manufacturing quality engineering role.
• Knowledge and experience with IATF 16949 and quality management system requirements.
• Experience supporting or managing a QMS in a manufacturing environment.
• Knowledge of ISO 9001 requirements and experience supporting certification maintenance and audit readiness.
• Experience leading or participating in internal, external, and customer quality audits.
• Knowledge of audit findings, corrective action plans, opportunities for improvement, and follow-up verification.
• Experience managing corrective and preventive action processes, including tracking actions through completion and verifying effectiveness.
• Familiarity with FMEA methodology, Control Plans, and other quality planning tools.
• Experience with PPAP, APQP, SPC, DOE, MSA, and statistical quality analysis.
• Proficiency with Minitab or equivalent statistical software to support SPC, DOE, and related quality activities.
• Strong document control and records management skills, including the ability to maintain accurate and current quality documentation.
• Strong organizational skills and attention to detail.
• Excellent written and verbal communication skills.
• Strong analytical, problem-solving, and continuous improvement skills.
• Strong computer skills, including Microsoft Word, Excel, and Outlook.
• Ability to work effectively with customers, engineering, operations, production, and other internal stakeholders.

Responsibilities

• Manage, maintain, and improve the Quality Management System (QMS) to ensure products and processes meet company standards and applicable customer requirements.
• Support the maintenance of ISO 9001 and IATF 16949 certifications and ensure ongoing compliance with applicable quality management system requirements.
• Lead, maintain, and improve internal and external audit programs, including certification and surveillance audit preparation, coordination, and follow-up.
• Lead customer audits and coordinate responses to audit findings, including opportunities for improvement (OFIs) and required corrective actions.
• Investigate and support the resolution of customer complaints, product returns, nonconformances, and internal quality issues.
• Lead or participate in structured problem-solving activities using appropriate quality tools to develop, implement, and sustain corrective and preventive actions.
• Support the management of the corrective action database to ensure actions are assigned, tracked, completed on time, and verified for effectiveness before closure.
• Apply Failure Mode and Effects Analysis (FMEA) methodology and associated Control Plans to evaluate product and process risks and support risk-reduction initiatives.
• Support customer quality requirements, including the preparation, review, and maintenance of PPAP, APQP, and other required quality documentation.
• Assist with customer plant visits, as needed, to evaluate product rejects and support quality issue resolution.
• Support continuous improvement activities designed to strengthen the QMS, improve process consistency, reduce variation, and enhance customer satisfaction.
• Support Measurement Systems Analysis (MSA), including Gage R&R studies, to help validate the reliability of measurement systems and quality data.
• Review, maintain, and improve document control processes to ensure documents remain accurate, current, accessible, and compliant with IATF requirements and internal procedures.
• Maintain and administer the SharePoint file management system for quality documentation and controlled records.
• Maintain awareness of internal calibration procedures, records, and documentation requirements, providing support as needed.
• Develop, maintain, and improve quality procedures, work instructions, forms, and other controlled documentation.
• Train team members on quality standards, document control requirements, and proper process documentation practices.
• Serve as a technical resource for quality-related questions and mentor supervisors, process engineers, technicians, and production employees on quality standards and improvement techniques.
• Identify opportunities to improve audit effectiveness, corrective action processes, documentation practices, and overall QMS performance.
• Support the implementation of process improvements and workflow automation where appropriate.
• Follow company policies, procedures, quality standards, and applicable safety requirements.
• Perform other duties as assigned.

Education

Bachelor's degree in Engineering

Tools

Minitab

Job description

Morales Professional is seeking a seasoned Quality Systems Engineer to lead and improve the QMS at our Fort Wayne, IN facility. You will maintain ISO 9001 and IATF 16949 compliance, drive internal and supplier audits, and manage document control and CAPA processes.

Collaborate with engineering, operations, and customers to strengthen quality performance, apply FMEA and Control Plans, and support PPAP/APQP activities while mentoring teams on best practices.