Job Description

The Lead CAPA Quality Engineer is the designated owner and subject matter expert (SME) for the Corrective and Preventive Action (CAPA) system at the Costa Rica manufacturing site. This role is responsible for ensuring CAPAs are risk‑based, data‑driven, timely, and effective, and that investigations lead to sustained systemic improvements across manufacturing processes and the site Quality Management System (QMS).

This position leads complex and high‑risk CAPAs arising from manufacturing operations, quality system processes or audit findings that impact the Costa Rica site. The Lead CAPA Quality Engineer enforces CAPA best practices, ensures rigorous root cause analysis, and verifies the effectiveness of corrective and preventive actions in alignment with regulatory expectations.

Operating with a high degree of autonomy within the Site Quality organization, this role serves as the escalation point for CAPA quality, timeliness, and effectiveness and acts as the primary CAPA contact during internal and external audits and inspections.

• Education / Educación:
• BS degree in Engineering, Life Sciences, or related field.

• Experience / Experiencia:
• At least 8 years of professional experience, with a bachelor’s degree, in positions with a similar level of responsibility, decision-making and problem solving.

• Specialized Knowledge (Desirable) / Conocimiento especializado (preferible):
• Statistical knowlegde, Project Management, Microsoft Office

• Languages ​​required for the position (Desirable) / Idiomas requeridos para el puesto (preferible):
• Spanish and 100% English

• of Duties and Responsibilities / Resumen de funciones y responsabilidades:

Essential Duties and Responsibilities:

• Acts as the Costa Rica site subject matter expert on CAPA, leveraging extensive knowledge of root cause analysis tools and applying risk management principles to CAPA initiatives and the Quality Management System.
• Leads and mentor teams in the CAPA process from risk/escalation assessment through CAPA effectiveness post closure, ensuring adequate containment actions are defined, a structured root cause analysis methodology is applied (e.g., 5-Why, Fishbone, Fault Tree Analysis, A3, DMAIC) to identify true systemic root causes, adequate Corrective and/or Preventive Actions are defined to prevent recurrence or occurrence of problems based on the identified root cause and, an appropriate effectiveness check plan is developed.
• Ensures adequacy of the statistical tools used throughout the CAPA process.
• Performs and participates in regular reviews of input sources to the NCE and CAPA processes to assist in determining escalations and coordinating with departments to ensure adequate status resourcing.
• Assists in the writing of the CAPA Investigation report applying technical writing skills and ensuring compliance with good documentation practices and regulatory standards.
• Verifies clear traceability between problem statement, root cause, corrective/preventive actions and effectiveness check plan.
• Monitors CAPA execution to ensure commitments are met and risks are mitigated in a timely manner.
• Evaluates KPI metrics to measure the effectiveness of the site CAPAs, providing detailed trend analysis and performance reports to senior leadership.
• Review and approve CAPA documentation to verify the completeness of activities, adherence to good documentation practices, and compliance with regulatory standards.
• Develops and maintains CAPA training content and deliver training to ensure consistent understanding across functions.
• Participates in site internal and external quality audits including support of front and/or back room workstreams.
• Supports in audit preparation efforts including communicating with applicable functional areas and collecting data to ensure audit efficiency.
• Participates in the collection of divisional Management Review materials.
• Leads responses to audit findings related to CAPA and ensure timely and effective remediation.
• Ability to modify, maintain, and create procedures and processes as applicable.

• Qualifications / Cualificaciones:
• Communication—must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.
• Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.
• Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.
• High proficiency with Microsoft Office suite to produce reports, analyze data, etc. effectively.
• Working knowledge of Medical Device Regulations, cGMP, CFR 820, ISO-13485.
• Risk management know how.
• Root cause analysis tools (Fishbone diagrams, 8D, DMAIC, SPC, Root Cause Failure Analysis, Kepner-Tregoe, etc.).
• Knowledge in corrective/preventive actions
• Proficiency with statistical and analytical tools to support data-driven decisions.

• Computer tools and knowledge level required (Desirable) / Herramientas informáticas y nivel de conocimiento requerido:
• Microsoft Office: Avanzado
• Internet: Yes
• E-mail: Yes
• Other Tools: Minitab, MS Project, Visio, Agile