Automation operator

The Opportunity

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.

Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

The Supervisor, Automation Operator is a key role responsible for overseeing and optimizing production processes. This includes operating and monitoring equipment, developing and updating KPIs and visual controls, supervising and training subordinate operators, ensuring compliance with regulations and safety protocols, and maintaining product quality through aseptic techniques.

The role involves holding team meetings, performing preventative maintenance, managing documentation, and leading initiatives to enhance efficiency and quality and driving continuous improvement efforts.

This role is located in Athens, Ohio.

The Responsibilities

Supervise, train, and mentor operators, including new hires, to ensure a skilled and competent workforce, team alignment, motivation, and competence.

Collaborates on the development of SOPs, MPIs and JSPs related to HVL line and labs.

Operate and monitor production line equipment, including advanced technology such as handling robots, ultrasonic welders, laser etchers, and test equipment.

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

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

Initiate NCMR requests for non-conforming parts and engage with Quality Engineering and management as necessary.

Manage material requisition (inflows), monitor outflows of completed parts, and fulfill production schedules to meet daily and weekly targets.

Ensure accurate and organized completion of production documentation and review documents comprehensively.

Monitor and control key performance indicators, ensuring OEE, output goals, and machine capabilities are met.

Ensure strict adherence to GMP, Environmental Health & Safety protocols, and PPE requirements.

Maintain clean and efficient workspaces, driving contamination mitigation efforts per established SOPs.

Run daily staff value stream stand-up meetings to communicate production goals (KPIs), address issues, and drive safety initiatives.

Communicate effectively within the team and with support groups, following escalation procedures for fast response.

Troubleshoot material and equipment concerns, responding to production issues and liaising with internal departments as necessary.

Initiate and participate in continuous improvement activities, including Lean Initiatives like Kaizen, to optimize processes and equipment.

Ensure compliance with work instructions and maintain detailed records for quality assurance and process improvement.

The Individual

Required :

High school diploma or equivalent required

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

Bachelor’s degree

The Key Working Relationships

Internal Partners :

Production Equipment Technicians, Engineers, Leadership Team,

The Work Environment

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.

Equal Employment Opportunity

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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Last updated : 2024-05-09