Manager, Document Control and Training

Artivion, Inc.•Austin, TX

41d

About The Position

The Manager, Document Control & Training, leads the Austin site's Document Control and Training programs to ensure compliance with applicable regulatory requirements and corporate quality system standards. This role manages day-to-day operations of document lifecycle management, quality records, and training program execution for a single site. The Manager is responsible for team performance, workflow prioritization, and continuous improvement within the scope of document control and QMS training.

Requirements

Bachelor's degree, preferably in Life Sciences.
Minimum of 5 years' experience in regulated industry with an in-depth knowledge of ISO 13485, Quality System Regulations, and cGMPs.
Experience supervising/managing a team in the medical device/pharmaceutical industry.
Must have ISO 13485 experience.
Advanced hands-on experience with electronic QMS systems.
Effective communication (verbal and written) and interpersonal skills
Strong analytical and problem-solving skills.
Must be detail-oriented, conscientious, and exhibit strong organizational skills.
Strong sense of urgency and ability to complete accurate work within deadlines.

Responsibilities

Leads the Document Management function for the site, ensuring controlled creation, revision, approval, obsolescence, retention, and storage of quality documents and records.
Manages workflow and priorities to ensure documents move through the system in a timely manner, including coordination of periodic document reviews.
Ensures documents originating externally and required for the quality management system are identified, controlled, and distributed appropriately.
Oversees site Record Retention activities, including archiving, retrieval, and secure storage processes.
Manages the site Training Program related to the QMS, including development and delivery of onboarding and ongoing training.
Provides oversight and support for e-QMS and related training system tools; acts as a resource for users and resolves routine system issues.
Supports implementation and maintenance of training programs outside the QMS (e.g., compliance, cybersecurity), including user support and coordination.
Monitors and evaluates training needs across the site and recommends improvements to enhance training effectiveness and compliance.
Manages direct reports, including workload direction, coaching, development, performance evaluations, and hiring decisions.
Participates in investigations of NCs, CAPAs, and related quality records, ensuring documentation accuracy and closure.
Supports internal and external audits/inspections related to Document Control, Training, and general QMS compliance.
Drives continuous improvement within the Document Control and Training processes while maintaining compliance.
Performs other duties as assigned to support business needs.