QA Leader, Medical Devices (Design Controls)

T45 Labs; Santa Clara (CA); Vor Ort; USD 127.000 - 150.000; Vollzeit

Zusammenfassung

VahatiCor is seeking a Quality Assurance Manager to lead a team of inspectors and quality engineers onsite in Santa Clara, CA. You will champion the Quality Management System, partner with R&D and Regulatory teams, and ensure procedures meet regulatory submissions for Class III cardiovascular devices.

The role requires 10+ years in quality, 3+ years in management, and hands-on oversight of design controls, risk management, and manufacturing quality.

Qualifikationen

• 10+ years in Product Quality or Quality Engineering with medical devices.
• At least 3 years in a managerial role.
• Direct experience with FDA and ISO 13485 compliance.
• Experience with design controls, risk management, and PMA/inspections.
• Ability to lead cross-functional teams and drive CAPA actions.

Aufgaben

• Lead QMS, ensure documentation, report to top management on effectiveness.
• Collaborate with R&D, Regulatory, Manufacturing to meet regulatory requirements.
• Oversee design transfer, supplier quality, and inspection readiness.
• Coordinate PMA readiness activities and internal/external audits.

Kenntnisse

Quality leadership

Regulatory compliance

Medical device

FDA 21 CFR Part 820

ISO 13485

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

VahatiCor is seeking a Quality Assurance Manager to lead a team of inspectors and quality engineers onsite in Santa Clara, CA. You will champion the Quality Management System, partner with R&D and Regulatory teams, and ensure procedures meet regulatory submissions for Class III cardiovascular devices.

The role requires 10+ years in quality, 3+ years in management, and hands-on oversight of design controls, risk management, and manufacturing quality.