Complaint Handling Specialist I

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 we continue to grow, we are seeking a Complaint Handling Specialist I. This entry-level professional will have demonstrated ability to complete complaint management process and play a role in the other types of investigations carried out by the Complaint Handling Unit. Will manage routine processes, data and/or sets of tasks, in addition to contributing work and knowledge within larger projects. Will operate under supervision and will provide assistance and support to the business as required. Will carry out various activities while consistently maintaining accuracy and attention to detail. An individual contributor who will work independently, have independent judgment and decision-making within the limits of established policies and procedures, communicating with other team members and peers to carry out work in a timely manner. This position is in Rochester, NY.

The Responsibilities

• Execute Complaint Investigations, Failure Investigations, vigilance reporting, and/or data analysis within the team. Research, collect data and respond to requests for vigilance reporting, health hazard evaluations and post market surveillance reports.
• Assist business partners on post market product safety and quality issues.
• Participate in projects as team member with specific identified deliverables.
• Support a continuous improvement culture with a focus on metrics, benchmarking and best practices.
• Provide support during internal and external audits.
• Provide input and support during escalation of safety and quality issues based on surveillance data.
• Maintain appropriate measures and indicators to support a high performance and continuous process improvement culture.
• Perform other work-related duties as assigned.

The Requirements

Required Qualifications

• Bachelor's degree in Science, Engineering or equivalent field of study.
• 0-2 years of work experience.
• Strong communication skills.
• Ability to work independently.
• Strong attention to detail.

Preferred Qualifications

• Medical device/IVD or clinical/blood-banking laboratory experience.
• Previous experience in a quality or regulatory role.

EOE/AA Disability/Veteran