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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 RoleAs we continue to grow as QuidelOrtho, we are seeking a Quality Technician II who will be responsible for assessing the completion and adequacy of the Device History Record (DHR) to support the final release of customer product and equipment. This position is in Rochester, NY.
The ResponsibilitiesReviews Device History Record (DHR) data entries for accuracy, completeness and compliance with specifications as per applicable departmental procedure(s) for review of quality records.
Follows detailed procedures documented in SOP's, work instructions, forms and on check lists.
Strong documentation and organizational skills are required.
Records and escalates exceptions to DHR and product release in the applicable quality management systems.
Ability to summarize data and coordinate with manufacturing supervisors the efficient/timely release of product.
Performs QA Review and Releases product through a final usage decision in SAP so that the product can be shipped for customer use.
Assists with the implementation of revisions, corrections and changes to procedures and methods associated wth the role. OTIS Change Author Experience.
Maintains accurate records for products and equipment and performance processes.
Maintains a record of DHR errors and generates nonconformance's when necessary to alert Quality Engineers , management and other applicable personnel of any issues.
Observes and participates in discussions with quality, engineering and other relevant departments to learn about and support corrective actions for reoccurring problems.
Ability to identify process improvement opportunities and participate on projects and teams.
OTIS Change Author Experience
Ability to compile metrics data and identify trends as opportunities for improvement.
Ability to represent DHR Review during internal/external audits.
Perform other work-related duties as assigned.
High School Diploma/GED with a minimum of 3 years' experience; or an Associate's degree and 1 year of experience or a Bachelor's degree or equivalent combination of education and experience.
Minimum of 12 months related work experience in a medical device or FDA regulated environment.
Working knowledge in good manufacturing practices per FDA and ISO requirements and/or regulations.
Working knowledge of Microsoft office tools for communication, data analytics and performance reporting- strongly desired.
Proficient in SAP, QERTS, LIMS, and OTIS
Process Excellence or Six Sigma training preferred
Ability to travel (10%)
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 orthorecruiting@orthoclinicaldiagnostics.com
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"At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career.
Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law."