Sr. Manager, Document Control & Corporate Training (Hybrid - Austin, TX) presso Artivion, Inc.

Company Overview

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. specializes in developing innovative medical devices aimed at addressing challenging cardiac and vascular conditions. Our Austin facility houses a diverse team dedicated to producing the On-X Mechanical Heart Valves. With over 1,400 employees globally and manufacturing sites in Atlanta, Austin, and Hechingen, Germany, Artivion serves healthcare professionals in over 100 countries. For more details, visit our website at www.artivion.com.

Position Objective:

To manage the activities of the Artivion Document Control and Corporate Training program to ensure operational compliance to applicable regulatory requirements and the corporate quality system.  This position works at a corporate level and across several sites to ensure harmonized and compliant quality systems in the areas of document control and training.  To ensure that all areas outlined under “Principal Responsibilities” are accomplished in an efficient, professional manner to support Artivion, Inc.

Responsibilities:

Essential functions include, but are not limited to:

• Manage the Document Management function for Artivion, including overseeing corporate document control, creation/revision/obsoletion and consistency of documents, and retention, maintenance and storage of quality records.
• Implement policies, procedures, and practices as they relate to Data/Documentation Control to ensure Quality System Regulations and ISO compliance.
• Create harmonized document templates and ensure consistent document format.
• Ensure that the status of all documents are managed to ensure a timely flow through the system and periodic reviews of documents are completed on time.
• Ensure that documents of external origin, determined by the organization to be necessary for the planning and operation of the quality management system, are identified and their distribution controlled.
• Manage Record Retention activities, including archiving and retrieval.
• Manage the Corporate Training Program related to the QMS.
• Develops appropriate QMS-related training and implements throughout the organization, including New Hire onboarding training.
• Manage the Corporate Training Program related to corporate level training governance and compliance, such as ethics/compliance and cybersecurity training.
• Support maintenance and implementation of specific training outside of QMS. Provide technical support to users of these systems.
• Identify and monitor training needs of the organization, and design, plan, and implement training programs, policies, and procedures to fulfill those needs.
• Oversees e-QMS software implementation and maintenance across company.
• Lead and Manage a team and develop skills and growth within team.
• Participate on corporate project teams
• Participate in audits/inspections and act as the Subject Matter Expert for Document Control and Training.
• Manage and control department budgets.
• Other duties as assigned.

Note:  Management retains the discretion to add or change the duties of the job at any time to support current business needs.

Qualifications:

• Bachelor’s degree, preferably in Life Sciences.
• Minimum of 8 years’ experience in regulated industry with an in-depth knowledge of ISO 13485, Quality System Regulations, and cGMPs.
• 5-7 years of experience 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

Benefits:

• Comprehensive Medical, Dental, and Vision
• Life Insurance
• Supplemental Benefits
• 401(k) with both Traditional and Roth options available
• Employee Stock Purchase Plan (ESPP)
• 10 Paid Company Holidays
• Competitive PTO plan
• Tuition Reimbursement

Equal Employment Opportunity Employer (EEO):
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law.