Quality Systems Specialist II: CAPA & Compliance Pro

Cirtec Medical Corp.; Santa Clara (CA); Presencial; USD 84.000 - 100.000; Jornada completa

Descripción de la vacante

Cirtec Medical Corporation is seeking a Quality Systems Specialist II to ensure adherence to the QMS within Quality Systems & Control. You will coordinate NCMR, CAPA, and complaint processes while supporting investigations and root cause analysis, partnering across R&D, Manufacturing and QA, and maintaining essential quality documents.

The role emphasizes training, process improvements, and compliance with GMP/ISO standards to sustain product quality for Class II/III devices.

Formación

• 2+ years of relevant experience in a regulated manufacturing environment.
• Experience analyzing data for patterns and trends.
• Familiarity with GMP/ISO standards.
• Strong English verbal and written communication skills.
• Proficient with Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Able to read, write and speak fluent English.

Responsabilidades

• Initiate, own, and/or close Nonconforming Material Reports (NCMRs).
• Initiate or support investigation/analysis of returned/complaint materials.
• Coordinate activities related to NCM, Complaint, RMA, and CAPA processes.
• Support investigation and root cause analysis of advanced/complex issues.
• Escalate material nonconformances to CAPA based on trending data.
• Communicate product performance via formal presentations to management committees.
• Maintain quality system documents related to NCMR, CAPA, and Complaint systems.
• Initiate or review document changes including quality procedures.
• Review quality documentation and records and update as required.
• Adhere to Cirtec Medical policies and procedures.
• Complete assigned tasks with minimal supervision.
• Respond and adapt to changing priorities with minimal disruption.
• Act as a CAPA Owner or support CAPA activities.
• Provide support to the Supplier Quality management group as needed.
• Support internal and external audits.
• Ensure adherence to training requirements for QMS elements, controls, processes, and procedures.
• Provide training on NCM Control, CAPA, etc.
• Support Corporate Quality Management System initiatives and continuous improvement.
• Calculate or monitor key quality metrics.
• Ensure compliance with regulatory standards.
• Ensure site personnel compliance with QMS training.
• Must be knowledgeable of Cirtec Medical QMS and requirements.
• Meet Cirtec training requirements.
• Follow PPE guidelines.

Conocimientos

Data pattern analysis

Cross-functional teams

English communication

Self-starter

GMP/ISO knowledge

Educación

Associates of Science Degree in Manufacturing, Engineering, or Technical Field

Herramientas

PowerBI

Descripción del empleo

Cirtec Medical Corporation is seeking a Quality Systems Specialist II to ensure adherence to the QMS within Quality Systems & Control. You will coordinate NCMR, CAPA, and complaint processes while supporting investigations and root cause analysis, partnering across R&D, Manufacturing and QA, and maintaining essential quality documents.

The role emphasizes training, process improvements, and compliance with GMP/ISO standards to sustain product quality for Class II/III devices.