Senior Quality Leader - MedTech (ISO 13485)

Energy Jobline ZR; San Jose (CA); On-site; USD 167,000 - 190,000; Full time

Benefits offered by this job

Medical – Dental – Vision – Life보험

Vacation and Sick Pay

401k

Job summary

Vantedge Medical in San Jose, CA is seeking a Senior Quality Manager to lead the site quality organization and oversee quality systems, engineering and control functions. You will work with the VP of Quality to drive process improvements and compliance across NPI programs and production, with minimal travel.

The role requires strong QMS knowledge, leadership experience in metal manufacturing, and the ability to partner with customers and suppliers.

Qualifications

• Bachelor Degree in Engineering is required.
• 8-10 years in a quality function within a regulated manufacturing environment, including at least 5 years in Quality Engineering and/or quality leadership.
• Background in metal manufacturing or a similar industrial sector is strongly preferred.

Responsibilities

• Directly manage Quality Engineering as a working manager; act as QE SME and use statistical techniques to detect trends and opportunities for improvement.
• Provide oversight to Quality Control and ensure inspection, containment, and disposition meet quality and schedule requirements.
• Lead significant quality issues, develop corrective actions, and communicate progress to site leadership and VP of Quality.
• Serve as Voice of the Customer in internal communications and in meetings focused on product/process improvement and cost reduction.
• Advise customers on manufacturing capabilities and support realization of requirements.
• Develop and review operating/quality procedures and manufacturing practices, collaborating with QC Manager.

Skills

QMS fundamentals

ISO 13485/9001

Statistical methods

Quality engineering

Process validation

Manufacturing knowledge

Customer communication

Education

Bachelor degree in Engineering

Tools

PFMEA

CMM

Job description

Vantedge Medical in San Jose, CA is seeking a Senior Quality Manager to lead the site quality organization and oversee quality systems, engineering and control functions. You will work with the VP of Quality to drive process improvements and compliance across NPI programs and production, with minimal travel.

The role requires strong QMS knowledge, leadership experience in metal manufacturing, and the ability to partner with customers and suppliers.