Bilingual Quality Trainer

Monroechamber; Lake Geneva (WI); On-site; USD 33,000 - 41,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Monroechamber is seeking a hands-on Training Program Specialist to manage and improve a paper-based training system in an ISO 13485 manufacturing environment. The role focuses on compliant training records, documentation, and metrics to ensure audit readiness in Lake Geneva, WI.

You will design bilingual English/Spanish training materials, develop a tiered competency model, and implement modern delivery methods while maintaining robust document controls.

Qualifications

• 3+ years of experience in training coordination within a regulated environment.
• Experience with ISO 13485 training and documentation requirements.
• Ability to create bilingual training materials (English/Spanish).
• Strong audit-readiness and documentation skills.
• Proficiency with Microsoft Office; experience with IQMS preferred.

Responsibilities

• Maintain a paper-based training system compliant with ISO 13485 requirements and traceability.
• Track training completion, retraining intervals, and training effectiveness.
• Prepare audit-ready training records and support internal and external audits.
• Design tiered training models and competency pathways.
• Develop bilingual English/Spanish training materials and coordinate translations.
• Collaborate with Manufacturing, Quality, and HR to align training with SOPs.
• Introduce modern training methods (videos, microlearning) while preserving document controls.
• Evaluate systems (IQMS) to improve training and qualification processes.

Skills

Bilingual English/Spanish

Training coordination

Audit readiness

Quality systems

Tools

IQMS

Microsoft Office

Job description

Position Title: Bilingual Quality Trainer Wage: $24.00-$30.00/hour Shift: 1st Hours: 7:00am-4:00pm

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.

Responsibilities

• 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

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 IND022.

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

We are proud to be an equal opportunity employer.