Associate Training Specialist

About the Role

This position is responsible for providing technical and administrative support for the Quality Systems department. The role involves managing documentation, coordinating training activities, and supporting continuous improvement initiatives to ensure compliance with regulatory standards.

Responsibilities

• Manage and maintain the Quality Management System (QMS) documentation, including document control, revision, and distribution.
• Coordinate and track employee training records and ensure compliance with training requirements.
• Support internal and external audit activities by preparing documentation and facilitating access to records.
• Assist in the development and implementation of quality system procedures and work instructions.
• Participate in continuous improvement projects and initiatives to enhance quality processes.
• Generate quality metrics and reports to monitor system performance and identify trends.
• Provide administrative support to the Quality Systems team as needed.

Requirements

• Bachelor's degree in a scientific, technical, or related field.
• Minimum of 2 years of experience in a quality systems or document control role within a regulated industry (medical device, pharmaceutical, or diagnostics preferred).
• Familiarity with ISO 13485, FDA 21 CFR Part 820, or similar quality standards.
• Proficiency with electronic document management systems (EDMS) and Microsoft Office Suite.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities.
• Excellent written and verbal communication skills.

Qualifications

• Experience with SAP or other enterprise resource planning (ERP) systems.
• Knowledge of Lean Six Sigma methodologies.
• Certification in quality (e.g., CQA, CQE) is a plus.

Skills

• Document control and records management.
• Regulatory compliance and audit support.
• Data analysis and reporting.
• Process improvement and problem-solving.
• Collaboration and cross-functional teamwork.