Quality System Specialist

Quality System Specialist

Unigen, headquartered in Newark, California, is a trusted partner for businesses seeking to power their next generation of products. Founded in 1991, we've grown into a leading provider of electronics manufacturing services (EMS), offering a comprehensive suite of solutions from design and manufacturing to supply chain management. From advanced memory modules to high-density storage devices, our solutions are engineered to meet the demanding needs of today's technology landscape. Our commitment to quality and innovation ensures that our partners have the tools they need to succeed.

At Unigen, you'll have the opportunity to work on cutting-edge projects and make a real difference. Working at Unigen means you'll be surrounded by other innovative companies, have access to top talent, and be close to world-class resources. We offer competitive compensation and a comprehensive benefits package, including 401(k) matching. This location, combined with our benefits, provides a unique advantage for those looking to thrive in the semiconductor industry.

Job Function: Quality Department Report to: Senior Quality Assurance Engineering Manager

Job Summary: The Quality System Specialist is responsible for developing, implementing, maintaining, and continually improving the organization's management systems, including Quality (ISO 9001/IATF 16949/AS9100/ISO 13485), Environmental (ISO 14001), Occupational Health & Safety (ISO 45001), and Information Security (ISO 27001). This role ensures compliance with applicable standards, legal requirements, and customer expectations, and drives a culture of continuous improvement across all management systems.

Primary Job Responsibilities:

1. Management System Development & Maintenance

• Develop, implement, and maintain QMS, EMS, OHSMS, and ISMS in alignment with business objectives, ISO standards, regulatory requirements, and customer expectations.
• Ensure effective integration and alignment of all management systems with core business processes.
• Maintain accurate documentation, procedures, and records to demonstrate compliance and support internal and external audits.
• Monitor changes in standards, regulations, and customer requirements, and update systems and processes as needed.
• Ensure ongoing compliance with legal, regulatory, and customer-specific requirements.
• Collaborate with relevant departments to prepare management review reports and coordinate management review meetings.
• Work with relevant departments to establish quality objectives and Key Process Indicators (KPIs), monitor progress toward achievement, and drive continuous improvement initiatives.
• Support effective risk assessment, hazard assessment, environmental emergency, health and safety emergency testing, and contingency testing as required by applicable management systems.
• Respond to customer questionnaires and surveys related to applicable management systems.

Audits & Compliance

• Coordinate with internal auditors for audits of QMS, EMS, OHSMS, and ISMS as required.
• Track and close nonconformities, corrective actions, and preventive actions (CAPA) related to management systems.
• Manage external audits and certification/recertification processes.
• Ensure employee awareness of applicable management systems.
• Collaborate with relevant departments on competence training programs.
• Promote a culture of quality, safety, environmental stewardship, and information security.
• Participate in cross-functional teams to drive process improvements and risk reduction in the organization's management systems.
• Analyze data and trends to identify opportunities for improvement.
• Support root cause analysis and problem-solving activities.
• Other tasks when assigned by Manager.

Requirement and Qualification:

• Associate's degree in related field.
• 2+ years of experience in management systems related to manufacturing company.
• Working knowledge of at least one of ISO 9001, ISO 14001, ISO 45001, ISO 27001, IATF 16949, AS9100, ISO 13485.
• Experience with internal/external audits and CAPA processes.
• Strong analytical, organizational, and communication skills.
• Internal auditor certification of at least one of applicable management system standards.
• Lead Auditor certification(s) preferred.