Quality Systems Engineer

onsemi is seeking a Quality Systems Engineer in our Hudson, NH site. The Quality Systems Engineer is responsible for developing, implementing, maintaining, and continuously improving the Quality Management System (QMS) to ensure compliance with customer, regulatory, and industry requirements. This role partners with Manufacturing, Engineering, Supply Chain, and Operations teams to drive quality excellence, process improvements, risk reduction, and compliance initiatives. The Quality Systems Engineer serves as a key resource for audits, corrective and preventive actions (CAPA), Coaching teams on QMS requirement adherence , and quality metrics.

Qualifications

• Bachelor's degree in Engineering, Quality Management, Manufacturing Engineering, Industrial Engineering, or a related technical field.
• 3+ years of experience in a quality engineering, quality systems, or manufacturing quality role.
• Experience maintaining Quality Management Systems within a manufacturing environment. (semiconductor preferred)
• Knowledge of quality standards such as ISO 9001 and IATF 16949.
• Experience conducting audits and managing corrective action programs.
• Strong problem-solving and root cause analysis skills.
• Proficiency with Microsoft Office applications and quality management software.
• Excellent written and verbal communication skills.
• Ability to execute complex projects, and self-direct and prioritize work

Preferred Qualifications

• ISO 9001 / IATF Lead Auditor Certifications
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with statistical analysis, SPC, MSA, and capability studies.
• Experience working with ERP, MES, or electronic QMS systems.
• Experience working with Control Plans and FMEA methodologies.

Key Competencies

• Continuous Improvement Mindset
• Analytical and Critical Thinking
• Attention to Detail
• Regulatory and Standards Compliance
• Project Management
• Process Optimization
• Cross-Functional Collaboration
• Effective Communication
• Problem Solving and Decision-Making

Working Conditions

• Manufacturing and office environment.
• Routine plant-floor interaction and occasional travel for audit activities.
• Ability to observe production processes and conduct on-site audits.

Success Measures

• QMS audit performance and compliance results.
• Reduction in quality defects, scrap, and rework costs.
• Timely closure of corrective actions and audit findings.
• Improved customer satisfaction and quality performance metrics.
• Successful implementation of continuous improvement initiatives.

Responsibilities

Quality Management System (QMS)

• Maintain and continuously improve the Quality Management System in accordance with applicable standards and regulations (e.g., ISO 9001, IATF 16949, RBA as applicable).
• Develop, review, and update quality procedures, work instructions, and system documentation.
• Coach QMS process owners on how to identify and close gaps to customer, regulatory, and industry requirements.
• Monitor QMS effectiveness through internal audits, data analysis, and performance metrics.

Audits & Compliance

• Plan, coordinate, and conduct internal audits.
• Support customer, registrar, and regulatory audits.
• Track audit findings and ensure timely closure of corrective actions.
• Ensure compliance with customer requirements, industry standards, and regulatory expectations.

Corrective and Preventive Actions (CAPA)

• Lead root cause investigations using methodologies such as 8D, Fishbone, 5 Whys, and Failure Mode and Effects Analysis (FMEA).
• Facilitate corrective and preventive action activities across functional teams.
• Verify effectiveness of implemented solutions and ensure sustainable process improvements.

Process Improvement

• Analyze quality data and identify opportunities for continuous improvement.
• Collaborate with manufacturing and engineering teams to reduce defects, scrap, rework, and customer complaints.
• Support Lean Manufacturing, Six Sigma, and continuous improvement initiatives.
• Drive standardization and best practices internally and to onsemi manufacturing locations.

Quality Metrics & Reporting

• Maintain quality performance dashboards and KPI reporting.
• Monitor trends related to nonconforming material, internal defects, supplier quality, and customer complaints.
• Present findings and recommendations to leadership and cross-functional teams.

Training & Support

• Train employees on quality system requirements, procedures, and best practices.
• Provide guidance to manufacturing and support teams regarding quality standards and compliance requirements.
• Promote a culture of quality throughout the organization.