Quality Management System (QMS) Manager

Direct Hire Quality Manager

Medical Device Manufacturing

Location: Hawthorne, Ca

Salary: $150K

Schedule: M- F: 7 AM -3:30P

We are seeking a Quality Manager to lead our Quality Management System (QMS), drive continuous improvement initiatives, and ensure the consistent production of high-precision, medical-grade components.

This is a hands-on leadership role responsible for quality assurance, compliance, audits, CAPA management, supplier quality, customer quality, and team development. The ideal candidate is detail-oriented, highly organized, and passionate about building a culture of quality and accountability.

Key Responsibilities

• Maintain and improve the Quality Management System in compliance with ISO 13485, FDA Quality System Regulations, and customer requirements.

• Lead internal audits, management reviews, and preparation for customer and regulatory audits.

• Oversee incoming, in-process, and final inspection activities.

• Manage calibration systems, metrology equipment, and inspection documentation.

• Lead root cause investigations and corrective/preventive action (CAPA) activities.

• Manage nonconforming materials, customer complaints, and quality-related corrective actions.

• Serve as the primary point of contact for customer quality issues, audits, and inspections.

• Oversee supplier quality activities, including evaluations, audits, and corrective actions.

• Track and report quality metrics such as scrap, rework, customer complaints, audit findings, and CAPA effectiveness.

• Lead, mentor, and develop Quality Inspectors, Quality Engineers, and other quality personnel.

• Drive a culture of compliance, continuous improvement, and documentation discipline throughout the organization.

Qualifications

• 5 years of quality experience in medical device manufacturing, precision machining, or another highly regulated manufacturing environment.

• Experience maintaining compliance with AS9100 standards

• Strong knowledge of ISO 13485 and FDA Quality System Regulations.

• Experience managing Quality Management Systems, audits, CAPA programs, and quality documentation.

• Understanding of GD&T, inspection methods, and metrology equipment, including CMMs.

• Experience leading and developing quality teams.

• Strong communication, problem-solving, and organizational skills.

• Bachelor's degree in Engineering, Quality, or a related field preferred.

What Success Looks Like

• Audit-ready quality systems and documentation.

• Effective CAPA processes with timely closure and measurable results.

• Reduced scrap, rework, and customer quality issues.

• Strong supplier performance and customer confidence.

• A well-trained, accountable, and high-performing quality team.

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