Manager, Operations Support

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:

The Operations Support Manager plays a pivotal role in leading and driving operational excellence and ensuring compliance across Artivion's facilities. This position is responsible for the development, implementation, and oversight of effective training programs that align with internal procedures and external regulatory standards. By partnering with cross-functional teams, the Manager ensures training curricula are current, completion rates are monitored, and targeted learning initiatives are delivered to enhance performance in alignment with Artivion's core values. This role ensures compliance with regulatory standards, drives continuous improvement, and fosters cross-functional collaboration to support business objectives.

Responsibilities:

Training Program Management

• Lead in designing, coordinating, and deliver operations training programs aligned with internal procedures and external regulatory requirements.
• Lead onboarding and refresher training for new and existing employees.
• Monitor training completion.

Operations Support

• Oversee daily OEM operations including processing, assembly, and final packaging.
• Review and update SOPs and customer requirements to ensure operational compliance.
• Support investigations and execution of Non-Conformances (NCs) and Corrective and Preventive Actions (CAPAs).
• Collaborate with cross-functional teams on validations and production-related initiatives.
• Develop and track Key Performance Indicators (KPIs); prepare reports and implement corrective actions.
• Conduct internal audits (Safety, 5S, Gemba walks, eGMP compliance) and support consumables management with Purchasing.
• Contribute to training plans and continuous improvement efforts.

Manager as Liaison Between Operations and Quality

The manager serves as a critical bridge between Operations and Quality teams, ensuring effective communication and collaboration when addressing non-conformances. They are responsible for:

• Identifying and Communicating Issues: Ensuring non-conformances are accurately reported and understood by both departments.
• Coordinating Corrective Actions: Facilitating root cause analysis, aligning on action plans, and ensuring timely implementation of corrective and preventive measures.
• Resource and Support Role: Acting as a knowledgeable resource to guide teams through quality standards, regulatory requirements, and operational constraints.
• Driving Closure: Monitoring progress, removing roadblocks, and ensuring all actions are completed and documented to achieve full resolution and prevent recurrence.

By maintaining transparency, accountability, and a collaborative approach, the manager helps uphold product quality and operational efficiency while fostering a culture of continuous improvement.

Cross-Functional Collaboration & Leadership

• Build strong partnerships with Engineering, Quality, Regulatory, and external stakeholders.
• Lead and develop high-performing teams across Operations, OEM, Operations Training, Manufacturing Compliance.
• Participate in corporate projects and continuous improvement initiatives.
• Manage departmental budgets, resources, and expenditures.
• Analyze KPI's and metrics to drive improvements and streamline processes.
• Perform other duties as needed to support business and regulatory compliance.

Beyond expectations set above, the position will be responsible for:

• Managing SOP revisions, updates, and periodic reviews
• Authoring and executing Non-Conformances (NCs) and Corrective and Preventive Actions (CAPA)
• Coordinating OEM business activities
• Supporting production validations (PQ, UAT, etc.)
• Maintaining key performance indicators (KPIs) through accurate data collection and reporting
• Overseeing inventory of operational consumables to ensure uninterrupted production workflows
• Corporate Training
• Change Control oversight for production-related activities
• Conformance Assessments
• Supporting internal and external audits, regulatory inspections, and quality initiatives with professionalism and efficiency.

Other responsibilities as assigned.

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical/scientific field; equivalent professional experience may be considered.
• Professional certifications such as Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma are preferred.
• Minimum of 8-10 years of experience in regulated industries such as medical devices, pharmaceuticals, or biomedical sectors.
• Extensive knowledge of FDA regulations, current Good Manufacturing Practices (cGMP), and ISO standards (including ISO 13485 and ISO 14971).
• Experience in pharma or med device.
• At least 5-7 years of leadership experience managing teams within the life sciences or medical device industry.
• Proficiency in Microsoft Office Suite and SAP inventory systems.
• Strong understanding of sterilization processes, including gamma, ETO, and steam sterilization, as well as environmental monitoring, equipment validation, and supplier oversight.
• Ability to analyze and implement systemic improvements to enhance product quality and operational efficiency.
• Skilled in presenting technical information to regulatory agencies and supporting audits and inspections.
• Familiarity with training methodologies is a plus.
• Exceptional verbal and written communication skills.
• Strong analytical and problem-solving abilities.
• Highly organized with meticulous attention to detail.
• Proven ability to manage multiple priorities in a fast-paced, deadline-driven environment.
• Self-motivated and capable of working independently while inspiring and guiding others.

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.