Quality System Specialist

Unigen Corporation; Newark (CA); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k)

Paid time off

Professional development opportunities

Job summary

Unigen Corporation, based in Newark, California, is seeking a Quality System Specialist. This onsite role focuses on developing, implementing, and maintaining the organization’s QMS, EMS, OHSMS, and ISMS to meet ISO standards and customer expectations.

You will drive continuous improvement across all management systems. Responsibilities include coordinating audits, maintaining documentation, updating processes, and leading CAPA activities.

Qualifications

• Associate's degree in a related field.
• 2+ years of experience in management systems for a manufacturing company.
• Experience with internal/external audits and CAPA processes.
• Internal auditor certification of at least one applicable management system standard.

Responsibilities

• Develop, implement, and maintain QMS, EMS, OHSMS, and ISMS in alignment with ISO standards, regulatory requirements, and customer expectations.
• Ensure effective integration and alignment of all management systems with core business processes.
• Maintain documentation, procedures, and records to demonstrate compliance and support audits.
• Monitor changes in standards, regulations, and customer requirements and update systems accordingly.
• Coordinate management review reports and meetings with relevant departments.
• Establish quality objectives and KPIs, monitor progress, and drive continuous improvement.
• Support risk assessment, hazard assessment, and emergency testing as required.
• Respond to customer questionnaires and surveys related to management systems.
• Coordinate with internal auditors for audits and manage CAPA activities.

Skills

Analytical skills

Organizational skills

Communication skills

Education

Associate's degree

Job description

About Unigen

Unigen is a global technology company providing innovative electronics manufacturing and product solutions to customers across diverse industries. With decades of industry experience and operations in key global markets, we combine engineering expertise, advanced manufacturing capabilities, and responsive customer service to deliver reliable, high-quality solutions—from product development through production and fulfillment.

Location and Work Arrangement

This position is based in Newark, California and is onsite.

Benefits

• Unigen offers a competitive compensation and benefits package, including medical, dental, and vision coverage; a 401(k) plan; paid time off; paid holidays; and professional development opportunities.
• Benefits are subject to eligibility requirements and applicable plan terms.

Job Title: Quality System Specialist

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

• 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.

Training & Awareness

• 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.

Continuous Improvement

• 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.

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.