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Ortho Clinical Diagnostics, Inc. Senior Product Surveillance Specialist in Rochester, New York

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity
As the company continues to grow, we are seeking a Senior Product Surveillance Specialist. The Senior Product Surveillance Specialist is typically a seasoned professional in IVDs. They are key members on critical initiatives and will manage routine processes and sets of tasks in addition to contributing work and knowledge within larger projects. They operate under minimal supervision and provide assistance and support to the business. This position is located in Rochester, NY.

The Responsibilities
Assists business partners on post market product safety and quality issues.
Executes complaint investigation and vigilance reporting within the team. Researches, collects data and responds to requests for vigilance reporting, health hazard evaluations and post market surveillance reports.
Participates in projects as team member with specific identified deliverables.
Provides input and support during escalation of safety and quality issues based on surveillance data.
Provides support during internal and external audits. May be required as SME.
Uses the OLAs for Individual Contributors to establish an environment of trust and success.
Maintains appropriate measures and indicators to support a high performance and continuous process improvement culture

The Individual
Bachelor's degree in Science or Engineering
A minimum of 5 years medical device / IVD or clinical/blood-banking laboratory experience. Has previous experience in a quality or regulatory role
Work visa sponsorship is not available for this position
#LI-LB1
#CB#

For this position we will not sponsor applicants for work visas.
Equal Opportunity

Ortho Clinical Diagnostics 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. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related 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

Supplemental Poster

Pay Transfer Notice

"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."

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