Manager, Operations Support

CryoLife • Austin, TX

79d

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• Familiarity with training methodologies is a plus.

Responsibilities

• 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.
• 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.
• Identify and Communicate Issues: Ensuring non-conformances are accurately reported and understood by both departments.
• Coordinate Corrective Actions: Facilitating root cause analysis, aligning on action plans, and ensuring timely implementation of corrective and preventive measures.
• Act as a knowledgeable resource to guide teams through quality standards, regulatory requirements, and operational constraints.
• Monitor progress, remove roadblocks, and ensure all actions are completed and documented to achieve full resolution and prevent recurrence.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Ambulatory Health Care Services
• Education Level: Bachelor's degree