We are looking for a Quality Engineering that:
\n
Il suo CV è pronto? Se sì, e se è convinto/a che questo sia il ruolo giusto per lei, si candidi il prima possibile.
\n
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.
\n
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.
\n
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.
\n
Essential Duties & Responsibilities
\n
Quality System Management
\n
- Support the implementation, maintenance, and continual improvement of the Quality Management System (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\n
- 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.
- Promote a strong customer‐focused and compliance‐driven quality culture.
Internal & External Audits\n
- Support internal, external, supplier, and regulatory audits.
- Support monitoring and implementation of corrective actions resulting from audit findings.
NCR & CAPA Process\n
- Act as CAPA and Nonconformance (NC) Owner for assigned records, supporting:
- Root cause analysis
- Definition and implementation of corrective and preventive actions
- Effectiveness verification
- Support 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\n
- 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.
Communication & Collaboration\n
- 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\n
- Bachelor's or Master's degree in Engineering or related technical discipline.
- Experience in Quality Assurance / Quality Engineering within the medical device or pharmaceu