Site Quality Leader - ISO 13485 & FDA Compliance

Balda-C-Brewer; Ontario (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Balda-C-Brewer seeks a Senior Manager, Site Quality in Ontario, CA to lead the quality department and ensure compliance with ISO 9001, ISO 13485 and FDA regulations. You will manage validation, inspection, document control, CAPA, metrology and product release activities, driving continuous improvement across the site.

The role requires 5+ years of leadership in pharma/medical device quality, a relevant bachelor’s degree, and strong communication skills.

Qualifications

• Bachelor’s degree with relevant field preferred.
• 5+ years leading and implementing quality systems in medical devices/pharma.

Responsibilities

• Lead and maintain ISO 9001, ISO 13485, and FDA 21 CFR 820 compliant QMS.
• Drive continuous improvement and validation activities across site quality functions.
• Oversee audits (ISO, internal, supplier) and CAPA processes.
• Develop training plans for site personnel and onboarding of new hires.
• Collaborate with manufacturing to enforce quality programs and resolve issues.
• Ensure products meet customer requirements and regulatory standards.

Skills

Facilitation

Conflict Management

Information Gathering & Processing

Interactive Communication

Partnering

Relationship Building

Research

Teamwork

Writing Skills

Concern for Safety

Proactive and self-motivated

Time management

Client focus

Education

Bachelor’s degree (sciences, chemical, pharmacy, plastics or engineering)

Tools

PC-DMIS

IQMS

Minitab

Job description

Balda-C-Brewer seeks a Senior Manager, Site Quality in Ontario, CA to lead the quality department and ensure compliance with ISO 9001, ISO 13485 and FDA regulations. You will manage validation, inspection, document control, CAPA, metrology and product release activities, driving continuous improvement across the site.

The role requires 5+ years of leadership in pharma/medical device quality, a relevant bachelor’s degree, and strong communication skills.