Technical Services Specialist III
Abbott Rapid Diagnostics
DO WORK THAT MATTERS.
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Technical Services Specialist III is within our Informatics business unit located at Charlottesville, VA. This role will be is responsible for addressing customer calls and emails of a more complex nature, relating to product inquiries, opinions/suggestions and complaints concerning a wide range of the company’s products and/or product families, under the minimum oversight of area management using professional concepts, technical knowledge, and company’s strategies, tactics, and policies and procedures formulated in association with management, with the objective of satisfactorily addressing the customer’s inquiry or complaint.
- Field customer calls and emails and apply troubleshooting skills to assist customers with appropriate responses to product inquiries, opinions/suggestions, and complaints, using strategies and tactics formulated by management. Contribute to guidelines for appropriate troubleshooting.
- Document cases in complaint handling system, using guidelines to ensure comprehensive and quality documentation. Accuracy and readability of written work; complaint and CAPA records including customer communications, study plans, protocols and reports. Contribute to guidelines for appropriate documentation.
- Able to assess a customer complaint for Medical Device Reporting requirements. Identify and escalate cases with potential regulatory actions. Advise management of significant product issues and unresolved customer issues.
- Monitor and evaluate case documentation. Track and manage open cases and follow up with customers in a timely manner.
- Handle multiple priorities on daily basis. Use time management skills to be productive and deliver positive, concrete results. Demonstrated flexibility with change.
- Interface with manufacturers’ product support investigative teams, vendors and field service providers re: case investigations and on-site service calls, acting to ensure appropriate and timely responses. May serve as liaison.
- Interface with various internal groups (Engineering, Operations, Quality Assurance, Regulatory, field personnel, marketing) concerning product and customer service issues.
- Practitioner of problem solving and root cause analysis tools and techniques. May conduct analysis of case data for tracking and trending, escalating appropriately. Study design and analysis of data generated to draw a valid conclusion.
- Document customer letters, job aids and other technical information.
- Participate in training. Share knowledge with others. Contribute to development of training plans and materials.
- Serve regularly as resource for other specialists in addressing customer issues based on experience and knowledge.
- Facilitate and contribute to implementation of new and/or standardized processes and programs.
- High standard of oral communication required for meeting facilitation and participation, customer interaction including calls, WebEx, site visits and audit either by customer or third party.
- Product knowledge including performance claims and Quality Agreements in place with customers. Apply advanced knowledge of diagnostics on product and technical level.
- Working knowledge of complaint handling and CAPA process in the context of ISO13485, the US Code of Federal Regulations, and territory-specific regulations.
- Work on assignments that are complex in nature where considerable and good judgment is required in addressing issues and making recommendations.
- Demonstrate strong service orientation and focus, using skills in customer service methods and techniques. Communicate effectively, professionally and respectfully. Build productive working relationships internally and externally.
- Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- Perform other duties & projects as assigned.
Experience and Qualifications
- BS/BA Required and/or five to eight years of related IT/Quality/customer support experience
- Advanced degree preferred including eight or more years related experience in customer support.
- Working knowledge of diagnostic industry on a clinical and technical level including knowledge of federal regulations related to clinical testing, diagnostics and medical device industry, e.g. FDA, ISO 9001, ISO 13485.
- Advanced knowledge of systems with software and hardware components.
- Excellent troubleshooting skills.
- Ability to work on issues of diverse scope where analysis of situations or data requires evaluation of identifiable factors.
- Demonstrate good judgment in selecting methods and techniques to determine appropriate actions and results.
- Excellent service orientation and focus, experience in customer service methods and techniques.
- Excellent verbal and written communication skills, able to convey appropriate information with clarity and effectiveness.
- Display initiative in performing responsibilities and accomplishing goals.
- Demonstrated skills in carrying out responsibilities and goals with minimal direction in an accurate, dependable manner.
- Collaborate effectively, serve as resource and role model, be flexible with change, handle multiple priorities, and consistently deliver concrete and positive results.
- Excellent computer skills including MS Office.
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