Quality Systems Lead: ISO, Audits & Continuous Improvement

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

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.