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Senior Product Support Specialist

Company: Apex Systems
Location: Charlottesville
Posted on: May 3, 2020

Job Description:

REMOTE OPPORTUNITY This role will lead and have responsibility for the complaint escalation process, provide product and technology support solutions to customers, and support resolution of on-market product quality issues. The position will operated under supervision and require to work collaboratively while also responsible for independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the quality system and consistent with regulatory requirements and business objectives. RESPONSIBILITIES Responsible for leading the complaint escalation process, including documentation, coordination of investigation, determination of risk, root cause and corrective and preventative actions. The liaison between OperationsSupport and Software Development teams to facilitate and coordinate resolution activities for on-market product quality issues. 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. Manages the decision-making process and creates a work environment that supports team effectiveness. Participates and on occasion leads team through investigations, risk assessments and corrective actions of CAPAs. Participates in defining Quality requirements within the design transfer, design control and improvement project teams. Consults to ensure that product safety and efficacy have been evaluated and issues related to safetypatient results are elevated for risk evaluation. Ensures complaints and nonconformances meet the requirements listed within the operating procedures. Evaluates complaints and nonconformances for product impact, completion of corrections, need for further investigation and need for global action. Recommend revisions where deficiencies are found. Assists in generating metrics to demonstrate timely completion of the activities list above supported by regular status reports to Quality Manager and interested parties. Regularly analyses Complaint records and On-Market Surveillance studies to identify trends. Report Trends, with recommendations via Quality Trend Review and Management Review Provides assistance to customers including problem solving, and technical information regarding the use of software applications. Provides the highest level of escalated support concerning the operation all Informatic products. Determines urgency level and communicates accurately with key stakeholders. Reviews functionality of how our software works when product issues are received. Maintains customer requests in Salesforce and tracks the progress of the incident through to resolution. Keeps informed and promotes awareness of all product changes. Highlights issues and presents possible resolutions. Seeks additional information when problem is beyond area of personal expertise. Actively participates in development and implementation of new systemsapplications. Contributes to the creation of the team's objectives, accepts team decisions and works toward their implementation displaying sensitivity to group dynamics, 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. BASIC QUALIFICATIONS EDUCATION Bachelor's Degree in Science or Engineering or related technical discipline and at least 5+ years of experience technical product support role. 8+ years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes Understanding and experience with Software Development Lifecycle Management, Agile methodology preferred. Experience with Salesforce, TCPIP, VPN Connectivity, Networks, IIS, HL7 interfaces, email client programs and protocols, VMWare, Crystal Reports, SQL Server, Medical terminology, HTML and XML. PREFERRED QUALIFICATIONS Strong problem-solving skills and necessary persistence to work around "roadblocks". Reviews and analyzes data, draws effective conclusions. Understands experimental design. Can apply knowledge to data analysis and problem-solving situation. Strong penchant for asking questions and a natural curiosity to understand the root cause of a technical issue. Ability to work in a fast-paced environment, handling multiple assignments simultaneously while ensuring the customer's issue has been addressed properly. Directly confronts rather than avoids conflicts, depersonalizes conflict situations by focusing on issues rather than personalities and actively searches for win-win solutions. Excellent listening skills with the ability to manage challenging customer interactions. Ability to communicate effectively with customers in a courteous and professional manner. Appropriately influences others to support a course of action. Influences activities without reliance on formal authority. Removes barriers that block goal attainment and drives change through the organization Ability to prioritize workload to ensure critical issues are handled in a timely manner. Demonstrates accountability for complying with Quality System requirements. Committed to improving quality and performance of all Informatics products. Exhibit professional behavior with both 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. COMPETENCIES Focuses on Customers - Promptly and effectively handles issues and problems. Focuses on Customers - Role models quality excellence, continuously improving for our customers. Drives for Results - Is resourceful, leverages resources, tools and technologies in order to be more effective and efficient. Fosters Collaboration - Avoids getting stuck in a "one right way" approach - remains open minded to new ideas. Fosters Collaboration - Actively develops a network to bring best solutions to the team or customer. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservicesapexsystemsinc.com or 844-463-6178.

Keywords: Apex Systems, Charlottesville , Senior Product Support Specialist, Other , Charlottesville, Virginia

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