Quality Management System; QMS Manager

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.

• 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.

• 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.

• 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.

Location:

Hawthorne, CA

Salary: $150K

Schedule:

Monday‑Friday, 7 AM – 3:30 PM