Senior Quality Manager — Medical Devices & Compliance

Cirtec Medical Corp.; Santa Clara (CA); Presencial; USD 140.000 - 165.000; Jornada completa

Descripción de la vacante

Cirtec Medical Corp. is seeking a Quality Manager in Santa Clara, CA to lead Quality personnel and resources, ensuring compliance with the Quality Management System in design, development, and manufacturing for Class II/III devices.

The role covers CAPA, risk management, audits, and continuous improvement, with a focus on regulatory compliance and cross-functional collaboration to support product development and sustaining manufacturing.

Formación

• Minimum 7 years in a regulated medical device environment with supervisory responsibilities.
• Quality or Regulatory certification (ASQ, Lead Auditor, etc.).
• Knowledge of ISO 13485, 21 CFR 820 (FDA cGMP/QSR), EU MDR requirements.
• Experience with Class II and Class III medical device development and manufacturing.
• Experience leading audits by customers and regulatory agencies.
• Ability to implement quality programs and drive continuous improvement.
• Strong written and verbal communication skills.

Responsabilidades

• Oversee Quality Management System compliance site-wide.
• Lead and mentor Quality engineering and Quality Control teams.
• Ensure regulatory and QMS requirements are met in product development and manufacturing.
• Drive CAPA, nonconformance, risk management, and supplier quality activities.
• Lead internal and external audits and implement corrective actions.
• Collaborate with cross-functional teams on design transfers and process improvements.
• Maintain documentation control and records retention processes.

Conocimientos

Quality leadership

Regulatory knowledge

Documentation control

CAPA

Risk management

Auditing

Communication

Coaching

MS Office

Educación

Bachelor in STEM field

Advanced degree preferred

Herramientas

Microsoft Word

Excel

PowerPoint

Access

PLM

MRP

Descripción del empleo

Cirtec Medical Corp. is seeking a Quality Manager in Santa Clara, CA to lead Quality personnel and resources, ensuring compliance with the Quality Management System in design, development, and manufacturing for Class II/III devices.

The role covers CAPA, risk management, audits, and continuous improvement, with a focus on regulatory compliance and cross-functional collaboration to support product development and sustaining manufacturing.