On-Site QC Leader - Medical Devices

Envista; Yorba Linda (CA); Presencial; USD 95.000 - 116.000; Jornada completa

Descripción de la vacante

Nobel Biocare in California is seeking a QC Supervisor to lead Quality Control activities for incoming materials and finished medical devices. You will oversee DHR closure, drive continuous improvement, and ensure compliance with approved procedures, with on-site work five days per week.

The role requires supervising QC staff, tracking workload, monitoring KPIs, and supporting audits and CAPA programs, all while maintaining a culture of quality and accountability.

Formación

• Bachelor's degree in Engineering, Life Science, Quality or related discipline preferred.
• Minimum 5 years of experience in Quality Control, Quality Assurance, or Manufacturing Quality within a regulated industry.
• Previous experience supervising or leading a team.
• Knowledge of ISO 13485 for medical device and 21 CFR 820.
• Communicates effectively (verbal and written) across functions.
• Strong analytical and documentation capabilities.
• Objective problem-solving skills with risk-based decisions under pressure.
• Fluent English.

Responsabilidades

• Lead and manage daily activities of QC inspectors and lab technicians
• Develop and maintain a tracking tool for resource allocation, workload management, and reporting
• Monitor team performance and KPIs
• Ensure inspections are performed according to procedures
• Perform inspection activities as needed
• Monitor and analyse nonconformances
• Drive continuous improvement initiatives using data and risk-based decisions
• Lead containment activities and support RCCA investigations and CAPA
• Ensure inspection plans and test procedures are effective
• Support internal and external audits and regulatory inspections
• Foster a culture of quality and accountability

Conocimientos

Team leadership

Quality control

Regulatory knowledge

Analytical thinking

Documentation

Communication (verbal/written)

Problem solving under pressure

Educación

Bachelor's degree (Engineering/Life Science/Quality or related)

Descripción del empleo

Nobel Biocare in California is seeking a QC Supervisor to lead Quality Control activities for incoming materials and finished medical devices. You will oversee DHR closure, drive continuous improvement, and ensure compliance with approved procedures, with on-site work five days per week.

The role requires supervising QC staff, tracking workload, monitoring KPIs, and supporting audits and CAPA programs, all while maintaining a culture of quality and accountability.