Quality Systems Analyst – ISO 9001 & Process Improvement

Hitachi; Boston (MA); On-site; USD 70,000 - 95,000; Full time

Job summary

Hitachi Energy USA Inc is seeking a Quality Systems Analyst to help maintain and improve our Quality Management System (QMS) in a manufacturing environment. You will work across functions to ensure compliance with ISO 9001:2015 and customer requirements while driving corrective actions and continuous improvements.

You will collaborate with teams to manage documentation, audits, and PFMEAs/Control Plans, contributing to enhanced product quality and operational excellence across our site in South

Qualifications

• Bachelor’s degree in Quality, Business, Engineering, or a related field, or 3+ years of relevant experience in quality systems, quality assurance, or manufacturing quality.
• Working knowledge of ISO 9001:2015 and Quality Management Systems.
• Experience supporting internal, external, or customer audits and audit readiness activities.
• Familiarity with CAPA, nonconformance management, and corrective action processes.
• Experience with document control systems, quality databases, and quality data analysis tools.

Responsibilities

• Maintain and improve the Quality Management System in accordance with ISO 9001:2015 requirements.
• Partner with cross-functional teams to ensure compliance with quality standards and customer expectations.
• Administer the electronic QMS, including document control, revisions, approvals, and periodic reviews.
• Coordinate nonconformance and corrective action processes, ensuring timely resolution and closure.
• Support the maintenance of PFMEAs and Control Plans to keep quality documentation accurate and current.
• Assist with internal, customer, and external audits, including preparation, execution, and follow-up activities.
• Participate in root cause investigations using structured problem-solving methodologies.
• Track quality system performance and support continuous improvement initiatives that strengthen operational effectiveness.

Skills

CAPA

Audit readiness

Data analysis

Problem solving

Cross-functional collaboration

Education

Bachelor’s degree in Quality/Engineering/Business

Tools

Document control

Quality databases

Data analysis tools

Job description

Hitachi Energy USA Inc is seeking a Quality Systems Analyst to help maintain and improve our Quality Management System (QMS) in a manufacturing environment. You will work across functions to ensure compliance with ISO 9001:2015 and customer requirements while driving corrective actions and continuous improvements.

You will collaborate with teams to manage documentation, audits, and PFMEAs/Control Plans, contributing to enhanced product quality and operational excellence across our site in South