Prentke Romich GmbH

Procurement

• Analyze raw material requirements and place purchase orders aligned with short‑ and long‑term production forecasts
• Partner with external manufacturing firms to support new product designs and prototyping efforts
• Collaborate with internal teams to provide pricing quotes, component availability, and procurement support
• Coordinate resolution of over‑shipments, short‑shipments, incorrect materials, and rejected or defective parts
• Select suppliers based on quality, cost, delivery, and overall production objectives

Procurement Agent

Security Engineer

• Design, build, and maintain systems that protect PRC‑Saltillo’s IT infrastructure from cyber threats.
• Engineer and maintain technical controls aligned with security policies, regulatory requirements, and company standards.
• Collaborate with the IT team to embed security guidance into infrastructure, systems, and solutions.
• Deploy, configure, and maintain security applications supporting the Information Security program.
• Perform audits and assessments of security engineering tools (including Mimecast, Portknox, Intune, Entra, Sophos, Graylog, DigiCert, and others) to ensure appropriate configuration and policy enforcement.

Compliance

• Ensure a robust and compliant quality management system (QMS) aligned with ISO 13485, FDA/QMSR, EUMDR, and other applicable standards.
• Provide leadership and oversight to personnel serving as primary contacts for external audits, assessments, and inspections, ensuring ongoing audit readiness.
• Lead management review processes and ensure effective follow up on quality system performance and improvement initiatives.
• Oversee interpretation and implementation of regulatory, legal, customer, and industry quality requirements.
• Ensure effective and compliant training programs for employees at all levels on quality standards, procedures, and continuous improvement methodologies.

Director of Quality and Regulatory Affairs

Manager

• Maintain an efficient, compliant quality management system (QMS) to ensure objectives are met and corrective actions are implemented as needed.
• Assign, monitor, and support corrective and preventive actions (CAPAs), observations (OBs), and opportunities for improvement (OFIs).
• Develop and deliver monthly CAPA, OFI, and OB reports for the Leadership Team and produce annual performance improvement reports.
• Collaborate with departments to develop, maintain, and ensure adherence to required processes and procedures.
• Facilitate and support assessments, audits, and inspections conducted by regulatory agencies and certifying bodies.
• Serve as the primary contact for QMS software, overseeing implementation, training, support, and ongoing improvements.
• Proactively manage organizational risk by implementing systems to prevent failures, reduce recall likelihood, and mitigate compliance risk.

Quality Systems Manager

Full-stack Engineer

• Collaborate with product managers and other software engineers to turn ideas into working software for dedicated hardware and personal computers.
• Design, implement, and document new software features and enhancements to existing products.
• Investigate, troubleshoot, and resolve bugs in existing software.
• Write clean, well‑documented, and maintainable code that follows established team coding standards.
• Provide thoughtful, constructive code reviews to support quality and knowledge sharing across the team.

Software Engineer

Content Marketing Manager

• Support the creation and maintenance of vocabulary programs and content for AAC devices and apps.
• Assist with multilingual content development, considering cultural nuances and accessibility standards.
• Collaborate with cross-functional teams to ensure content aligns with user needs and company goals.
• Contribute to non-vocabulary content such as device access tools and communication features.

Procurement Agent

Security Engineer

Director of Quality and Regulatory Affairs

Quality Systems Manager

Software Engineer

Content Support