Quality Manager

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

Quality Manager | Union City, CA

Seeking an experienced Quality Manager to lead our quality systems, compliance, and continuous improvement initiatives. This is a hands-on leadership role overseeing ISO 9001/13485 compliance, audits, CAPA, customer complaints, supplier quality, and quality team development. The ideal candidate brings 10+ years of progressive manufacturing/quality experience, strong problem-solving skills, and expertise in regulated manufacturing environments. Experience with ISO 13485, auditing, SPC/Minitab, CAPA, and Lean methodologies is highly valued. Join a collaborative team where your leadership directly impacts quality, customer satisfaction, and operational excellence.

salary: $135,000 - $155,000 per year

shift: First

work hours: 7 AM - 4 PM

education: High School

Responsibilities

• Develop company strategy to ensure product quality is acceptable with appropriate and demonstrable data
• ISO9001:2008, ISO13485:2003 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 review and timely action with customer issues, complaints, or rejects
• Effective and timely communication with all departments with regard to product quality and customer standards
• Communicate and track Customer Requirements
• All customer compliance for quality reporting, certifications, and capability analysis
• All customer audits
• Document IQ, OQ, PQ for all equipment and "critical processes"
• Optimization of customer satisfaction through improved operations
• Target 100% customer lot acceptance and 100% on-time delivery
• Implementation of productivity and quality metrics to minimize costs and enhance efficiency
• Effective planning and layout of workflow, equipment, and operations
• Recruiting, hiring, coaching, and developing staff
• Job descriptions, goals and objectives, one on one and team communications, etc.
• Developing and optimizing efficiency of workforce (direct labor as a percentage of sales)
• Budget and contingency planning
• Ensures adherence to annual budgets

Skills

• Quality Assurance
• Quality Control
• Product Inspection
• Leading

Qualifications

• Years of experience: 10 years
• Experience level: Manager

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Experience

• Manager
• 10 years

Education

• High School