Senior Quality Manager - ISO 9001/13485 | CAPA & Lean

Randstad USA; Union City (CA); On-site; USD 135,000 - 155,000; Full time

Job summary

Randstad USA in Union City, CA is seeking an experienced Quality Manager to lead our quality systems, compliance, and continuous improvement initiatives. This hands-on leadership role oversees ISO 9001/13485 compliance, audits, CAPA, customer complaints, supplier quality, and quality team development.

The ideal candidate brings 10+ years in regulated manufacturing, strong problem-solving skills, and expertise in ISO 13485, auditing, SPC/Minitab, CAPA, and Lean methodologies.

Qualifications

• 10+ years of manufacturing/quality experience.
• Experience with ISO 9001/13485 and regulated environments.

Responsibilities

• Develop strategy to ensure product quality with data.
• ISO9001/13485 and ITAR certification and compliance.
• Guide company in additional strategic certifications.
• Internal Audit Schedule.
• Coordinate and present Management Review Meetings in accordance with ISO requirements.
• Ensure timely action on customer issues, complaints, or rejects.
• Communicate and track Customer Requirements.
• All customer audits and quality reporting.

Skills

Quality Assurance

Quality Control

Product Inspection

Leading

Education

High School

Job description

Randstad USA in Union City, CA is seeking an experienced Quality Manager to lead our quality systems, compliance, and continuous improvement initiatives. This hands-on leadership role oversees ISO 9001/13485 compliance, audits, CAPA, customer complaints, supplier quality, and quality team development.

The ideal candidate brings 10+ years in regulated manufacturing, strong problem-solving skills, and expertise in ISO 13485, auditing, SPC/Minitab, CAPA, and Lean methodologies.