SRMS Engineer 2
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More information about this job:
Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the global clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks, and labs in more than 120 countries, Ortho’s high-quality products and services enable healthcare professionals to make better-informed treatment decisions.
For the immunohematology community, Ortho’s blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho brings sophisticated testing technologies, automation, information management, and interpretation tools to clinical laboratories around the world to help them run more efficiently, effectively and improve patient care. Ortho’s purpose is to improve and save lives with diagnostics and it does that by reimagining what’s possible. This is what has defined Ortho for more than 75 years, and it’s what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com.
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.
Highly independent individual performs analysis of complaint data and identifies product quality trends to provide inter-departmental feedback for investigation and to resolve product quality issues. The focus is on complaint vigilance regulatory compliance and escalation of post market quality issues. Performs in accordance with Company and Corporate policies, regulatory requirements and franchise strategies.
- Performs analysis of customer complaint data, monitors, and identifies product quality trends to provide inter-departmental feedback for investigation and to resolve product quality issues, focuses on complaint vigilance, regulatory compliance, field service partnership and customer satisfaction.
- Participates in group and self initiated training to gain competency in Ortho and non- Ortho product and process, laboratory practice, regulatory compliance knowledge. leadership, planning and organziation skills.
- Position requires strong leadership and organization, and planning skills with the ability to work cross-functionally with a diverse work force, and complex product portfolio and customer base. Excellent communication skills and ability to build and maintain relationships at all levels in the organization, including external customers and regulatory agencies.
- Prepares Health Hazard Evaluations in collaboration with Medical/Clinical Affairs and presents product quality issues at site quality reviews. Works with WW Implementation and GPCI to implement required field action(s). Provides input into corrective actions related to complaint management process and procedures and monitors progress to ensure effectivity.
- Supports regulatory inspections for complaint data, complaint process and quality issues related to associated field action (s) and vigilance reporting.
- Analyzes complaint investigations and perpares assessments of reportability for individual complaints.Prepares and submits US Regulatory Reports as required.
Education & Experience
- Degree required : BA/BS
- Degree desirable : MA/MS/MBA
- Education in subjects closely related to clinical laboratory or appropriate experience.
- Immunohaematology, Blood Banking or Clinical Diagnostics experience an advantage.
- Related Experience : minimum 2 to 4 years.
- Independent & autonomous, doesn't need direct supervision.
- Able to handle changing priorities and requests.
- Enjoys a challenge and problem solving.
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.