Quality Systems Engineer

Position Summary

This position is responsible mainly for maintaining and improving document control processes and maintaining and improve the Quality Management System.

Essential Duties & Responsibilities

• Establishes and exectes department objectives, determines and communicates workload prorities to personnel.
• Follow policies and procedures pertaining to best documentation practices.
• Provides training for document control processes.
• Ensures documentats are readily available in electronic format and accessible to all employees.
• Develops SOPs and DPs required for control of documentation and documentation activities and maintain the effectiveness of the Document Control System.
• Provides performance input to manager to aid with the performance review process.
• Ensures production documentation is controlled and changes are managed per documented procedures.
• Coordinate the process for Provides Change Order and release of new documentation and production transfer. Creates and processes change orders as assigned.
• Maintain the record retention system and retrieves documents and records from storage in a timely manner as assigned.
• Mantain external documents required for the Quality System.
• Implement and maintain the Process Performance Monitoring Audits, follow up execution, non-conformances report initiation and completion.
• Key contact to provide information required from the Manufacturing Site activities to certifications or regulatory compliance.
• Act as Non-Conformance Material Reports (NCMR) Coordinator.
• Participate in the investigation of customer complaints.
• Implement actions required to improve the effectiveness of the quality system and the quality culture of the site.
• Support execution of Corrective Actions.
• Support internal and external audits.
• This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (inluding knowledge of all standards, government occupational health and environmental regulations and statutues related to the site).
• Engages others, promot, and participate in Environmental, Health and Safely initiatives, focusing on continouos improvement.
• Engage others, promote and participate in 5s initiatives to contribute in the continuous improvement of our site.

Minimum Qualifications, Education & Experience

• BS Degree with additional training or experience in supervision and 5-7 years of related experiences. required.
• Experience with Technical Documentation and ERP/PLM systems in a global environment, preferred.
• Medical Device exerience preferred.

About Us

At ICU Medical, we drive clinical innovation to solve real challenges in healthcare.

With the integration of Hospira Infusion Systems and Smiths Medical (2022), we are now a global leader with a comprehensive portfolio of essential IV therapy and critical care solutions designed for hospitals, home care, and alternate care sites.

Our approach allows us to offer:

IV sets and needle-free connectors, clinically proven to reduce bacterial transfer.

The broadest portfolio of smart infusion pumps, covering large volumes, pain management, and ambulatory care.

Advanced IV medication safety software, with high interoperability with EHR systems.

Strong manufacturing and supply capabilities in IV solutions.

Furthermore, at ICU Medical, we are firmly committed to equal opportunity, promoting a diverse, inclusive, and respectful work environment where all individuals have fair access to professional development opportunities.

We remain ready to bring quality, innovation, and value to more areas than ever before.