Quality Systems Leader: ISO 9001/13485 & Audits

WorldBridge Partners - Leaders in Recruiting and Executive Search; Chino (CA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Bonus program

Work-life balance with flexible hours

Promotion from within

Job summary

Our client, a world-class plastics manufacturer, seeks a hands-on Quality Manager to lead the Quality Management System and quality team. You will ensure regulatory compliance and drive continuous improvement across manufacturing.

The ideal candidate has extensive experience with ISO 9001/13485, audits, root cause analysis, and leading quality initiatives in a fast-paced environment. Opportunities for growth and cross-functional collaboration are highlighted.

Qualifications

• Bachelor's degree in Engineering, Quality, Manufacturing, Business Management, or related field.
• Minimum of five years of QA or quality control experience.
• Minimum of three years in a Quality Management or Quality Leadership role.
• Experience supporting ISO 9001 and ISO 13485 QMS.
• Lead/audit certification for ISO 9001 and/or ISO 13485 preferred.
• FDA compliance experience preferred.
• Strong root cause analysis, corrective actions, and continuous improvement knowledge.
• Knowledge of SPC, Kaizen, Lean, Six Sigma, and related quality methodologies.
• ASQ CQE or related certifications preferred.

Responsibilities

• Lead, maintain, and improve the Quality Management System.
• Ensure ISO 9001, ISO 13485, FDA compliance and other quality standards.
• Plan, coordinate, and support internal and external audits.
• Maintain and control quality documentation and records.
• Lead quality training programs for manufacturing and quality personnel.
• Investigate quality issues and lead root cause analysis and corrective actions.
• Develop and monitor Corrective Actions and track KPIs.
• Drive quality and continuous improvement initiatives across manufacturing.
• Collaborate with production, engineering, and cross-functional teams to reduce defects.

Skills

Leadership

Communication

Organizational skills

Problem-solving

Education

Bachelor's degree in Engineering, Quality, Manufacturing, Business Management, or related field

Job description

Our client, a world-class plastics manufacturer, seeks a hands-on Quality Manager to lead the Quality Management System and quality team. You will ensure regulatory compliance and drive continuous improvement across manufacturing.

The ideal candidate has extensive experience with ISO 9001/13485, audits, root cause analysis, and leading quality initiatives in a fast-paced environment. Opportunities for growth and cross-functional collaboration are highlighted.