Quality ManagerMedical Device ManufacturingLocation: Hawthorne, Ca
Salary: up to $150K
Schedule: M- F: 7 AM -3:30P (Occasional Saturdays)
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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PandoLogic. Keywords: Medical Device Manager, Location: Hawthorne, CA - 90251
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