Direct Hire Quality Manager
Job Description
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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