Operations Manager – Medical Devices

We are seeking a driven and professional Operations Manager to lead and develop our clients new Service Centre in Irvine, California. The successful candidate will join a dynamic team, working with the latest surgical and imaging technologies to ensure smooth and efficient operations. This role is ideal for a team player with a passion for process optimization, leadership, and excellence in medical device servicing.

Responsibilities:

• Lead the development of operational readiness for the Service Centre in Irvine.
• Establish and implement technical support strategies, processes, and procedures for Service & Repair activities, including material readiness, turn-around time, decontamination, maintenance, and repair.
• Prepare and execute the qualification and validation of Service Centre equipment and processes.
• Develop, train, and mentor staff in customer service, analytical troubleshooting, root cause analysis, and other tools.
• Present capital budgeting and expense forecasts to higher management to support business needs and cost optimization initiatives.
• Provide leadership and strategies to ensure high-quality, timely, and cost-effective repairs.
• Ensure adequate capacity and process controls for uninterrupted customer service flow.
• Collaborate with Customer Service to ensure customer satisfaction and drive improvements.
• Work closely with the Quality department to maintain operational excellence and audit readiness.
• Recommend and implement employee development programs to enhance staff capabilities.
• Provide direction and support to team members to ensure work objectives are met.
• Ensure compliance with company policies and procedures, including GMP, ISO, and Environmental requirements.

Requirements:

• Bachelor’s degree (B.A. or B.S.) in a technical discipline or business.
• Minimum of 3 years of managerial experience, with at least 2 years in medical device servicing.
• Strong technical skills with experience in project leadership and supervisory roles.
• Proven problem-solving and resolution abilities.
• Excellent communication, leadership, and team management skills.
• Ability to work independently with minimal guidance.
• Experience in making effective management presentations and writing formal reports on departmental metrics.
• Preferred experience in setting up a medical device Service Centre.
• Familiarity with regulated environments (GMP, ISO, EHS).
• Knowledge of manufacturing, operations, supply chain, distribution, and logistics is a plus.
• Experience with process and equipment validation is preferred.
• Some travel, both domestic and international, may be required.

Occupational Code: 11-9111 Medical and Health Services Managers