Quality & Compliance Training Lead

• Own and manage the company’s training program within the QMS in compliance with ISO 13485 and applicable regulatory requirements.
• Ensure training processes, procedures, and records meet internal and external audit expectations.
• Maintain the integrity, accuracy, and completeness of training records within the electronic QMS or learning management system (LMS).
• Ensure compliance with training documentation requirements for regulatory inspections and audits.
• Develop, coordinate, and manage onboarding training programs for new employees.
•  Responsible for administering trainings as needed.  
• Ensure timely completion of required onboarding training assignments.
• Coordinate role-based training requirements in collaboration with department managers.
• Support qualification and competency tracking for job-specific training requirements
• Assign, track, and monitor employee training completion and compliance status.
• Maintain accurate and up-to-date training matrices and curricula.
• Ensure timely documentation of training completion, including attendance records and assessments.
• Generate training compliance reports, metrics, and dashboards for management review.
• Ensure training system alignment with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements.
• Support internal and external audits by providing training records, reports, and compliance evidence.
• Identify gaps in training compliance and implement corrective actions as needed.
• Continuously improve training processes, tools, and systems to increase efficiency and effectiveness.
• Support implementation of new or updated processes through training rollouts.
• Work with HR to ensure alignment of onboarding and training processes with organizational requirements.
• Develop and maintain training KPIs, including training completion rates, overdue training, and compliance trends.
• Provide regular training compliance reports to management.
• Support management review activities with training system performance data.
• Conduct quarterly training documentation review ensuring compliance within ISO 13485 and internal procedures.

• Experience managing training systems, LMS platforms, or QMS training modules strongly preferred.
• Working knowledge of ISO 13485 and FDA QSR requirements related to training and competency. Prior experience providing informal leadership, coordination, or oversight of junior staff preferred.
• Strong understanding of training system requirements in a regulated environment.
• Excellent organizational and documentation management skills.
• Ability to manage multiple training programs and deadlines simultaneously.
• Strong attention to detail and compliance mindset.
• Experience developing or maintaining training content and materials.
• Strong communication and facilitation skills.
• Proficiency in Microsoft Office and learning management or QMS systems.
• Ability to work cross-functionally and influence training compliance across departments.
• Demonstrates strong presentation skills and the ability to deliver effective training.
• ISO 13485 or GMP training experience preferred.
• Instructional design or training development certification is a plus.
• ASQ certifications (CQA, CQIA, or similar) are an advantage.

• Associate or Bachelor’s degree in Quality, Education, Life Sciences, Engineering, or related field preferred.
• 2–5 years of experience in training coordination, quality systems, or regulated industry environment (medical device preferred).

Powered by JazzHR