Solventum · 17 hours ago

Sr Director Training & Document Control (Solventum)

Antioch, IL

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$222K/yr - $271K/yr

12+ years exp

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Medical Device

No H1B

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Responsibilities

Lead and oversee the development, implementation, and management of the training programs and document control functions.

Provide strategic leadership for the Training and Document Control teams, driving initiatives to improve performance, efficiency, and quality across all functions.

Oversee the development and execution of training content, programs, and materials, including new hire onboarding, regulatory compliance training, quality systems training, and product-specific education.

Oversee the creation, revision, approval, and archiving of all critical documents, including standard operating procedures (SOPs), work instructions, training materials, and regulatory filings, ensuring compliance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards.

Manage and improve document control systems to ensure that all documents are appropriately managed, stored, and accessible, maintaining version control and audit trails.

Qualification

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Training ManagementDocument ControlQuality Management SystemsFDA RegulationsISO 13485Leadership ExperienceLearning Management Systems (LMS)Document Management Systems (DMS)Regulatory AffairsProject Management

Required

Bachelor's degree or higher AND (twelve) 12 years of experience in training, document control, and/or quality management/quality systems within the medical device or healthcare industry.

At least 10 years of leadership experience in managing teams within a regulated environment, preferably within a medical device or pharmaceutical company.

Knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant regulatory standards.

Preferred

A Master’s degree or advanced certifications in a relevant area (e.g., Project Management, Quality Management, Regulatory Affairs) is preferred but not required.

Direct leadership of document control and/or training teams preferred.

Experience with Learning Management Systems (LMS), Document Management Systems (DMS), and other relevant software tools is a plus.