job specification

Job Information

Posted: 19.05.2026

Job reference: cd27ada8890e171069a724cdb33555e1

Client / Employer: ICU Medical

Position Summary

The Quality Engineer is responsible for ensuring that processes, products, and quality systems comply with applicable regulatory requirements and company standards, while actively contributing to the maintenance and continuous improvement of the Quality Management System (QMS) at ICU Medical Latina.

This role supports and contributes to the management and improvement of key quality system processes, including customer complaints handling, investigations, CAPA and nonconformance management, and calibration activities, ensuring effectiveness, traceability, and regulatory compliance.

The Quality Engineer supports internal and external audits, contributes to continuous improvement initiatives through a strong analytical and data‑driven approach, and promotes a proactive quality culture across the organization. The role ensures that quality system procedures are properly implemented and maintained in compliance with applicable regulations and standards, including EU MDR, ISO 13485, ISO 14971, FDA QSR, and related requirements.

Quality System Management

• Support implementation, maintenance, and continual improvement of the QMS.
• Manage and support CAPA, nonconformities, change controls, and the SOP lifecycle in accordance with internal procedures.
• Support special projects and continuous improvement initiatives as assigned.
• Apply an engineering and analytical approach to identify risks, trends, and opportunities within the QMS.

Customer Complaints Process

• Manage the end‑to‑end customer complaints process for the site, ensuring all product complaints are assessed, investigated, documented, and closed in compliance with regulatory and company requirements (ISO 13485, MDR, FDA QSR).
• Support complaint process oversight, ensuring timely and accurate execution in line with defined KPIs.
• Coordinate and support complaint investigations in collaboration with Manufacturing, Engineering, R&D, Regulatory Affairs, and Quality Control.
• Ensure proper documentation, traceability, and record retention for all complaint files.
• Perform data analysis and trend evaluation of complaint data using structured methodologies and Excel‑based tools.
• Support CAPA initiation and follow‑up when complaint trends or investigations indicate systemic quality issues.
• Support audit readiness and participate in internal, external, and regulatory inspections.
• Oversee storage and traceability of returned complaint samples.

Internal & External Audits

• Support internal, external, supplier, and regulatory audits.
• Support monitoring and implementation of corrective actions resulting from audit findings.

NCR & CAPA Process

• Act as CAPA and Nonconformance (NC) Owner for assigned records, supporting:
• Root cause analysis
• Definition and implementation of corrective and preventive actions
• Effectiveness verification
• Coordination of the CAPA/NC process to ensure compliance, consistency, and timely closure.
• Prepare reports and metrics, performing trend and data analysis to identify improvement opportunities.

Calibration Process

• Coordinate calibration activities for measurement and test equipment.
• Maintain calibration schedules and ensure execution within defined intervals.
• Possess the technical capability to verify and assess the proper functionality of measurement and test equipment, by supervising calibration activities and confirming compliance with approved standard test methods and reference standards.
• Manage calibration records to ensure traceability and compliance with ISO 13485 and FDA QSR.
• Coordinate with internal stakeholders and external calibration service providers.
• Review calibration certificates and support equipment‑related investigations, including out‑of‑tolerance conditions.
• Prepare calibration metrics and support data‑driven improvements.
• Collaborate effectively with cross‑functional teams.
• Communicate quality topics using clear, analytical, and data‑supported communication.
• Participate in site and corporate meetings and reviews.

Minimum Qualifications, Education & Experience

• Bachelor’s or Master’s degree in Engineering or related technical discipline.
• Experience in Quality Assurance / Quality Engineering within the medical device or pharmaceutical industry.
• Knowledge of GMP / GDP requirements and regulated environments.

Knowledge & Skills – Technical & Analytical

• Strong analytical skills and engineering mindset.
• Experience with data analytics, trend analysis, and KPI monitoring.
• Advanced proficiency in Microsoft Excel.
• Experience with root cause analysis and corrective action implementation.
• Strong technical writing skills.
• Fluent English, written and spoken.

Knowledge & Skills – Interpersonal

• Strong interpersonal and collaboration skills.
• Ability to work effectively within cross‑functional teams.
• Ability to manage multiple priorities and meet deadlines.
• Proactive attitude and continuous improvement mindset.

This role operates in both office and controlled production/laboratory environments and may involve hands‑on interaction with measurement and calibration equipment. Compliance with quality, safety, and EHS procedures is required.

Occasional lifting of light equipment and use of PPE may be required.

Travel is expected to be less than 5%.

Working Conditions and Supervision

• Works under general supervision with defined objectives.
• Plans and executes assigned responsibilities independently.
• Actively supports Environmental, Health & Safety (EHS) initiatives.

#J-18808-Ljbffr