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.

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 Role

The Metrologist is responsible for the planning, development, implementation, administration and management on all test measuring instruments and systems used throughout the facility to ensure that all regulated compliance policies are met at Quidel.  Directs and coordinates the daily activities in the calibration, testing, verification, and preventative maintenance services.  Makes decisions regarding the technical aspects in the calibration, testing and verification parameters.  Develops calibration methods and techniques based on the principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements.  Makes changes to system requirements and any necessary repairs in order to restore instrument/equipment to original specifications in a cost-effective manner.  Performs on the spot decisions to support and maintain critical processes related to analytical and diagnostic instrumentation.  In addition, evaluates new equipment procurements, create new and/or update calibration methods and procedures.

This role is located in Athens, Ohio.

The Responsibilities 

Actively manages the calibration and maintenance program to ensure compliance with FDA, ISO and Canadian regulations.  This includes ensuring that existing and new equipment, tooling, measuring devices, and fixtures are evaluated and maintained to within prescribed specifications.  Also, the management of equipment databases of equipment activity and location.

Supervises calibrations and preventative maintenance activities by employees and external service contractors.  Assists all department personnel on equipment issues as it pertains to malfunctioning equipment and/or measuring applications.

Manages departmental budget and associated activities.

Creates documentation used in the calibration program containing specifications, work instructions, work standards, quality records, issue out of tolerance reports, coordinate with the following affected areas: product investigations containment activities, and corrective actions

Develops or revise equipment or measuring system validations (IQ/OQ) procedures for installation and operation of laboratory and production equipment.

Performs calibrations and troubleshooting for instruments and measuring systems.

Project management functions to include timelines and budgets as needed.

Develops measures for calibration system adherence and effectiveness.  Reviews as found data from calibration system to determine if calibration intervals for equipment have been set appropriately.  Reports results at management reviews, and operations reviews as required.  Expedites equipment in and out of the facility for recalibration and certification

Carries out duties on compliance with established business policies.

Performs internal and external audits as required.

The Individual

Required:

High school diploma or equivalent

4-8 years’ experience working in a metrology field

Minimum 4 years’ experience working with an FDA, ISO 9001 compliant system

Experience in calibration and troubleshooting techniques

Experience conducting routine quality audits

Experience working in fast paced manufacturing environment

This position is not currently eligible for visa sponsorship. 

Ability to work on a wide range of instruments and equipment.

Ability to manage and train department personnel on lab instruments.

Ability to effectively communicate with different levels of management.

Excellent organizational skills and the ability to prioritize multiple tasks.

Ability to write instructions and procedures, including IQ/OQ documents.

Ability to work independently.

Advanced computer skills including file management, (MS Office) Work, Excel.

Ability to create graphs, charts and give presentations.

This position is not currently eligible for visa sponsorship. 

Preferred:

B.S. degree in science

The Key Working Relationships

Internal Partners:

Purchasing, Receiving Inspection, Quality Engineering, Manufacturing, Engineering

External Partners:

Service Contractors and Outside Vendors/Regulatory Agencies

The Work Environment

The work environment characteristics are representative of an office, laboratory, and manufacturing environment. Flexible work hours to meet project deadlines. Occasional travel required.  Travel includes airplane, automobile travel and overnight hotel.

The Physical Demands

Position requires ability to lift, push, pull (moving instruments and equipment) up to 20 lbs. on occasion.  Up to 50% of time at the desk on computer/ meetings/ writing/ documenting activities, doing analytical work. Walking, standing, and sitting for long periods of time 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. Must have the ability to operate lab equipment. Position requires use of Personal Protective Equipment 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 recruiting@quidelortho.com.

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