Quality System Specialist

Unigen•Newark, CA

About The Position

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.

Requirements

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.

Nice To Haves

Lead Auditor certification(s) preferred.

Responsibilities

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.
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.
Others task when assigning by Manager.