Senior Quality Leader - MedTech, QMS & Compliance

Vantedge Medical Company; San Jose (CA); On-site; USD 167,000 - 190,000; Full time

Job summary

Vantedge Medical in San Jose is seeking a Senior Quality Manager to lead the site's quality organization, reporting to the VP of Quality. You will oversee Quality Systems, QE, and QC, direct the QE and QC teams, and partner with customers and suppliers on process improvements.

The role requires 8–10 years in a regulated manufacturing environment, with at least 5 years in quality leadership, a Bachelor in Engineering, and strong PFMEA/validation skills.

Qualifications

• Hands-on PFMEA, process qualification, and validation expertise.
• Strong knowledge of ISO 13485 and ISO 9001.
• Experience in QA leadership within metal manufacturing environments.

Responsibilities

• Directly manage Quality Engineering as a QE SME.
• Lead Quality Control and MRB processes.
• Partner with customers and suppliers to drive improvements.
• Develop and maintain QMS documentation.
• Lead internal audits and 24/7 audit readiness.

Skills

Quality Leadership

PFMEA

Process Validation

QMS Fundamentals

ISO 13485/9001

Cross-functional

Communication

Education

Bachelor Degree in Engineering

Tools

CMM

Metrology Equipment

Job description

Vantedge Medical in San Jose is seeking a Senior Quality Manager to lead the site's quality organization, reporting to the VP of Quality. You will oversee Quality Systems, QE, and QC, direct the QE and QC teams, and partner with customers and suppliers on process improvements.

The role requires 8–10 years in a regulated manufacturing environment, with at least 5 years in quality leadership, a Bachelor in Engineering, and strong PFMEA/validation skills.