Quality Assurance Complaints Handling Specialist

Position: Quality Assurance Complaints Handling Specialist Location: Sparks, MD Duration: 6 Months Total Hours/week: 40 Shift: 1st Shift Client: Medical Devices Company Job Category: Healthcare Level of Experience: Entry-Level Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT) Work days/hours: M - F 8am - 5pm Education: High School Diploma or associate degree Job Description Under the direction of PMQ Field Action Manager, the Quality Assurance Representative will interact with internal and external customers to provide and process information in response to inquiries, concerns and requests concerning products and services. The Quality Assurance Representative will also act as a liaison supporting customers through the complexity of multiple business and department infrastructures focusing on business-critical items while meeting the goals, objectives, and demands of the organization and adhering to policies and procedures. Key customer-facing activities include case creation for more complex scenarios, inbound/outbound calls, efficient handling and resolution of escalated issues and queries, and supporting customer relationships within assigned business specialty areas. Duties (for this position) Execute the logistical processes for client field actions, including but not limited to communicating with distributors to collect customer information. Conduct all administrative activities such as faxing, mailing, and filing of recall notifications. Maintain customer information. Facilitate the replacement process with customer service and/or field service. Conduct recall effectiveness checks. Interact with external customers in the field action process from inception to completion. Resolve customer concerns by pinpointing problems to offer the best course of action and following up to ensure customer satisfaction. Maintain a positive image when interacting with customers. Provide excellent communication, patience, understanding, and tact, often under difficult circumstances. Document information in system. Communicate directly with Quality Team to answer specific questions regarding complaints and replacement product shipments being sent back for a quality assessment. Triage complex customer inquiries, understand appropriate parties to resolve, and minimize the number of hand-offs for the customer. Ensure compliance with all client policies and procedures. Route calls to appropriate departments for further assistance. When multiple departments are involved, resolve and call back the customer. Make outbound calls to various customers to verify receipt of corrective action notifications. Navigates large medical facilities to identify correct parties to acknowledge corrective action notices. Maintain detailed records of outbound calls such as representative names, titles, disposition of any products. Provide training to personnel involved in overall complaint process as directed by management. Participate in all training classes including product training, regulatory training, compliance training and any testing involved. Maintain annual competencies through training and documentation of training. Interact with cross-functional teams as needed regarding questions related to the complaint file. Demonstrate technical competencies in mechanical, clinical, and functional areas relating to all client products. Remain current in product knowledge and upgrades to complaint handling systems. Maintain expert knowledge level of the complaint handling system. Provide training to peers as requested by management. Raise any escalated concerns to the next level of management. May perform other duties as required. Minimum Requirements/Knowledge Knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations desired. Product knowledge: understanding of product usage and the ability to differentiate between significant and non-significant health risks to either patient or healthcare worker. Ability to handle complex customer inquiries and receive, review, and process purchase orders. Ability to work with customer system administrators and clinicians. Proven ability to maintain a professional demeanor when handling complex user issues and high-pressure situations. Excellent customer service skills with strong attention to detail, excellent organizational skills, ability to handle multiple tasks simultaneously, and maintain confidentiality. Skills Take ownership and think independently with minimal supervision. General knowledge of producing metrics and building reports. Strong analytical, deductive reasoning, and listening skills. Communicate precisely and accurately to all levels of the organization. Strong interpersonal and project management skills. Identify creative solutions to complex customer issues; think outside the box. Excellent time management and multitasking skills. Excellent written and verbal communication skills. Works well in a team environment. Strong personal commitment to quality, customer service, and patient safety. Motivated, self-directed, and able to work with minimal supervision. Continuous and versatile learner. Education BA or BS degree preferred and/or combination of education and relative experience in lieu of a degree. Certifications Licensed Medical Professional desired such as Registered Nurse (RN), Med Technologist, Biomedical Engineer. Experience Minimum 1+ years of experience with medical terminology, nursing, clinical or laboratory knowledge and familiarity with client products. Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations. #J-18808-Ljbffr