Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics. Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.
With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.
Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.
Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.
Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.
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.
As the company continues to grow, we are seeking a Product Surveillance Group Lead.
This position is considered a subject matter expert in product vigilance. They are accountable for the success of projects and will have significant amounts of critical organisational and technical knowledge. They operate under little to no direct supervision and provide independent guidance to the business. They are responsible to the day to day management and supervision of Product Surveillance Engineer(s) responsible for assessment of potential health and safety complaints for reportability and completion of regulatory vigilance reports against reporting timelines world-wide. Responsible for staff development, goal-setting and appraisal. Responsible for the completion complaint reportability assessments allocated to themselves. Ability to complete reportability assessments, trending activities and escalation of priority issues to SQIR and PQR forum as needed. Ability to present complaint data and analysis to the business eg: QSMR. Ability to balance tactical execution of vigilance activities against team supervision and oversight. Ability to partner with Manager to develop strategic direction for the team to improve team effectiveness and efficiency
Provides independent vigilance guidance to business partners on post market product safety and quality issues.
Leads complaint investigation and vigilance reporting within the team and for own activities. Defines data and information required for vigilance reporting, health hazard evaluations and post market surveillance reports.
Is a project leader and may be responsible for operating within a budget. Will provide input on budget allocation and prioritisation.
Leads escalation of safety and quality issues based on surveillance data.
Will act as SME in internal and external audits.
Is a role model for the OLAs for Individual Contributors
Mentors team members to establish a high performance and continuous process improvement culture, driven by metrics, benchmarking and best practise.
Bachelor’s degree in Science or Engineering
A minimum of 7 years medical device / IVD or clinical/blood-banking laboratory experience.
Has previous experience in a quality or regulatory role. Experience leading teams an advantage
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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