CAPA Systems Engineer, Senior Staff
Aviso de fuente externaen Confluent Medical Technologies
Lead complex CAPA investigations, ensure regulatory and Quality Management System compliance, and drive improvements to product quality and process capability.
Salario
No especificado
Ubicación
Alajuela, Costa Rica
Tipo de empleo
Tiempo completo
Modalidad
No especificado
CAPA Systems Engineer, Senior Staff
Alajuela, Costa Rica
Descripción del empleo
About the role
Confluent Medical Technologies is seeking a primary subject matter expert for the Corrective and Preventive Action (CAPA) process within a medical device manufacturing environment. This role provides senior-level Quality Systems leadership, leads complex and high-risk CAPA investigations, and drives improvements to product quality, process capability, and quality system effectiveness.
The role ensures compliance with applicable regulatory requirements and internal procedures, serves as a strategic technical resource for cross-functional teams, mentors CAPA owners and Quality personnel, and represents CAPA processes during internal, customer, Notified Body, and regulatory audits. It operates with a high degree of independence, using expert judgment, risk-based decision-making, and advanced problem-solving methods to resolve complex quality issues and strengthen the overall Quality Management System.
Responsibilities
- Serve as the senior subject matter expert and process owner delegate for the CAPA process, ensuring consistent execution in accordance with applicable regulations, standards, and internal Quality Management System requirements.
- Lead and facilitate complex CAPA investigations associated with audit findings, nonconformances, complaints, process deviations, supplier issues, field performance, and quality system breakdowns.
- Apply advanced root cause analysis methodologies, including 5 Whys, Fishbone/Ishikawa, fault tree analysis, process mapping, statistical analysis, and risk-based problem solving, to identify true systemic causes.
- Develop and review corrective and preventive action plans addressing immediate containment, correction, root cause, systemic risk, implementation controls, and long-term prevention.
- Define and assess CAPA effectiveness criteria, including objective evidence, measurable outcomes, sustainability checks, and linkage to risk management, complaints, nonconformances, audits, and process performance.
Datos clave
- Leads complex and high-risk Corrective and Preventive Action (CAPA) investigations.
- Represents CAPA processes during internal, customer, Notified Body, and regulatory audits.
- Uses advanced root cause analysis and risk-based problem-solving methods.
Preguntas frecuentes
What does this role involve?
It provides Quality Systems leadership as the primary subject matter expert for the CAPA process and leads complex, high-risk investigations.
What responsibilities does the role include?
Responsibilities include root cause analysis, developing and reviewing corrective and preventive action plans, and assessing CAPA effectiveness criteria.
Does the role participate in audits?
Yes. It represents CAPA processes during internal, customer, Notified Body, and regulatory audits.