QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Automation Operator Lead is a key role responsible for overseeing and optimizing production processes. This includes operating and monitoring equipment, supervising and training subordinate operators, ensuring compliance with regulations and safety protocols, and maintaining product quality through aseptic techniques. The role involves performing preventative maintenance, managing documentation, and leading initiatives to enhance efficiency and quality.

This role is located in Athens, Ohio.

• Operate and monitor production line equipment, ensuring efficient workflow, meeting production targets, and optimizing processes.

• Supervise, train, and mentor subordinate operators, ensuring a skilled and competent workforce, and providing ongoing training and guidance.

• Ensure strict adherence to GMP production documentation, Environmental Health & Safety protocols, and PPE requirements, utilizing aseptic techniques for product integrity.

• Monitor and report on Overall Equipment Effectiveness (OEE), conduct first article inspections, and perform quality checks throughout the manufacturing process.

• Train new operators, ensuring full competence and establishing cross-training initiatives.

• Perform general preventative maintenance on all production line equipment to minimize downtime and maintain operational efficiency.

• Follow established equipment cleaning and cleanliness monitoring procedures.

• Manage material requisition for daily production needs, outflows of completed parts, and fulfillment of daily/weekly production schedules.

• Ensure accurate and organized completion of production documentation, comprehensively reviewing documents as needed.

• Conduct equipment change-overs and line clearances to minimize downtime and ensure smooth transitions between different products, batches, or shifts.

• Maintains clean and efficient workspaces and drives contamination mitigation efforts.

• Run daily staff stand-up meetings (M1 level) to communicate production goals, address issues, drive safety initiatives, and ensure team alignment and motivation to achieve production KPIs.

• Lead Lean Initiatives, e.g., Kaizen event leader, and manage performance of staff towards department and company goals, providing feedback on performance.

• Perform other duties and projects as assigned, working on complex assignments that require considerable judgment and initiative.

Required:

• High school diploma or equivalent

• 4-6 years of related experience in a technical automation manufacturing environment, with at least 2 years in a supervisory or lead role

• Knowledgeable of federal and other regulations, e.g. QSR's, ISO, ISO 13485, CMDR.

• Experience with high complexity, semi-automated production equipment

• Knowledge of MS Office and software systems used in manufacturing

• Ability to perform manufacturing operations with a high degree of quality, skill, and efficiency

• Solid understanding of manufacturing systems (documentation, compliance, inventory control, production scheduling/ controls)

• Solid understanding of the product and manufacturing processes

• Strong knowledge of GMP, Documentation Practices

• Demonstrates commitment to the development, implementation and effectiveness of Quidel Quality Management System per ISO, FDA and other regulatory agencies

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Preferred:

• Technical degree or certification

Internal Partners:

Production Equipment Technicians, Engineers, Leadership Team,

The work environment is representative of a clean room/dry room and highly technical manufacturing line, requiring adherence to safety protocols and flexible work hours to meet project deadlines. Position requires ability to lift up to 50 lbs. on a regular basis. May be required to perform repetitive manufacturing processes (e.g., manual loading and handling of sub-assemblies, material transferring between work cells, loading of parts into hoppers etc.) up to 50% of workday. Walking, standing, and/or sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at .

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