Bilingual Quality Trainer

Bilingual Quality Trainer

We are seeking a hands-on Training Program Specialist to manage and improve a paper-based training system while helping to mature the overall training program within an ISO 13485-regulated manufacturing environment. The immediate priority is maintaining compliant training records, documentation, and metrics to ensure audit readiness. The longer-term focus will include developing a tiered competency model, creating bilingual English/Spanish training materials, and implementing enhanced training delivery methods.

This is a temporary assignment of approximately 3 months in Lake Geneva, WI.

Bilingual Quality Trainer Responsibilities include but are not limited to:

• Maintain a paper-based training system compliant with ISO 13485 requirements, ensuring document control and traceability
• Track training completion, retraining intervals, and training effectiveness
• Maintain training metrics and reports for leadership and audit purposes
• Prepare audit-ready training records and support internal and external audits
• Assist with addressing training-related CAPAs
• Design and implement a tiered training model, including entry-level, qualified, and trainer-level
• Develop competency requirements, skill matrices, and qualification pathways
• Collaborate with Manufacturing, Quality, and HR to align training with processes, SOPs, and system changes
• Develop and administer bilingual English/Spanish training materials
• Coordinate translation and verification of training content
• Introduce and manage modern training methods such as interactive modules, videos, and microlearning while maintaining ISO 13485 document controls
• Evaluate available systems and leverage technology to improve training and qualification processes
• Utilize IQMS, where applicable, to explore integrated training and qualification capabilities
• Support continuous improvement initiatives related to employee training and qualification

Bilingual Quality Trainer Requirements:

• 3+ years of experience in training coordination, quality systems, manufacturing operations, or a similar role within a regulated environment
• Working knowledge of ISO 13485 training and documentation requirements or similar quality management system standards
• Strong recordkeeping skills with a high level of attention to detail
• Strong audit-readiness and compliance mindset
• Experience developing skill matrices and competency-based qualification paths
• Strong written and verbal communication skills
• Ability to create clear, practical, and effective training materials
• Proficiency with Microsoft Office applications and comfort working with data tracking and reporting
• Preferred experience with IQMS, particularly training, qualification, or document control modules
• Preferred bilingual English/Spanish skills or experience developing bilingual training materials
• Preferred medical device or life sciences manufacturing experience
• Preferred experience creating interactive, video-based, or digital training content within a controlled/documented environment
• Highly detail-oriented, organized, and compliance-focused
• Strong ability to collaborate across Manufacturing, Quality, and HR
• Excellent communication and stakeholder management skills
• Continuous improvement mindset with the ability to quickly build structure, processes, and tools
• Strong facilitation skills and the ability to work effectively with a diverse, multilingual workforce
• Self-directed and comfortable working in a hands-on manufacturing environment
• Standard PPE is required when entering production areas
• Must follow all site safety, quality, and GMP requirements
• Background check and drug screening may be required based on site requirements