Medtech Quality Manager: QMS & Compliance

Cirtec Services GmbH; Santa Clara (CA); On-site; USD 140,000 - 165,000; Full time

Job summary

Cirtec Medical Corporation in Santa Clara, CA is seeking a Quality Manager to lead Quality personnel and resources, ensuring QMS compliance and supporting product development and sustaining manufacturing programs.

The role oversees QMS activities, CAPA, audits, and cross-functional collaboration, with focus on design controls, risk management, and continuous improvement. A senior-level position with strong communication skills is required.

Qualifications

• Bachelor in STEM field required; advanced degree preferred.
• Min 7 years in regulated medical devices with leadership duties.
• ASQ or Lead Auditor certification desirable.
• Knowledge of ISO 13485, 21 CFR 820, EU MDR.
• Experience with Class II/III medical device development and manufacturing.

Responsibilities

• Oversee Quality Management System compliance and governance.
• Promote and ensure awareness of regulatory and QMS requirements across the site.
• Lead Management Review meetings and report on QMS performance and improvements.
• Manage CAPA, complaint analysis, and metrics reporting.
• Lead Quality Engineering for Design & Development and Sustaining Manufacturing.
• Supervise Quality Control for incoming, in-process, final inspections and release.

Skills

Quality Management

Regulatory compliance

Quality engineering

cGMP

Audits

Communication

Leadership

Problem solving

Education

Bachelor in STEM

Advanced degree preferred

Tools

Microsoft Office

Job description

Cirtec Medical Corporation in Santa Clara, CA is seeking a Quality Manager to lead Quality personnel and resources, ensuring QMS compliance and supporting product development and sustaining manufacturing programs.

The role oversees QMS activities, CAPA, audits, and cross-functional collaboration, with focus on design controls, risk management, and continuous improvement. A senior-level position with strong communication skills is required.