Quality Assurance Complaints Handling Specialist

Location: Sparks, MD • Duration: 6 months • Schedule: M–F, 8 am–5 pm • Pay rate: $20–25/hr

About the role

Under the direction of the PMQ Field Action Manager, the Quality Assurance Representative interacts with internal and external customers to provide and process information in response to inquiries, concerns, and requests about products and services. Acting as a liaison, the representative supports customers through complex business and department infrastructures, focusing on business-critical items while meeting organizational goals and adhering to policies and procedures.

Responsibilities

• Execute logistical processes for client field actions, including:
  • Communicating with distributors to collect customer information
  • Conducting administrative activities such as faxing, mailing, and filing recall notifications
  • Maintaining customer information
  • Facilitating the replacement process with customer service and/or field service
  • Conducting recall effectiveness checks
• Interact with external customers throughout the field action process from inception to completion
• Resolve customer concerns by identifying problems, offering solutions, and following up to ensure satisfaction
• Maintain a positive image when interacting with customers, often under difficult circumstances
• Document information in systems and communicate directly with the Quality Team regarding complaints and replacement product shipments
• Triage complex customer inquiries, identify appropriate parties for resolution, and minimize hand-offs for the customer
• Ensure compliance with all client policies and procedures
• Route calls to appropriate departments; if multiple departments are involved, take ownership to resolve and call the customer back
• Make outbound calls to verify receipt of corrective action notifications
• Navigate large medical facilities to identify the correct party to acknowledge corrective action notices
• Maintain detailed records of outbound calls, including representative names, titles, and product dispositions
• Provide training to personnel involved in the complaint process as directed by management
• Participate in training classes, including product, regulatory, compliance, and any associated testing
• Maintain annual competencies through training and documentation
• Interact with cross-functional teams regarding questions related to complaint files
• Demonstrate technical competencies in mechanical, clinical, and functional aspects of client products
• Remain current in product knowledge and complaint handling system upgrades
• Maintain expert-level knowledge of the complaint handling system
• Provide training to peers as requested by management
• Escalate concerns to the next level of management as needed
• Perform other duties as required

Requirements

• 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 ability to differentiate between significant and non-significant health risks to patients or healthcare workers
• Ability to handle complex customer inquiries and process purchase orders
• Ability to work with customer system administrators and clinicians
• Proven ability to maintain professionalism in high-pressure situations
• Excellent customer service skills, including strong interpersonal skills, attention to detail, and organizational skills
• Ability to handle multiple tasks simultaneously and maintain confidentiality

Qualifications

• Minimum 1+ years of experience with medical terminology, nursing, clinical, or laboratory knowledge, and familiarity with client products
• Minimum 2+ years of experience in complaint handling, the medical device industry, customer relations, complaint trending, or FDA/ISO regulations
• BA or BS degree preferred and/or combination of education and relative experience in lieu of a degree
• Licensed Medical Professional (e.g., Registered Nurse, Medical Technologist, Biomedical Engineer) desired

Skills

• Ability to take ownership and work independently with minimal supervision
• General knowledge of producing metrics and building reports
• Strong analytical, deductive reasoning, and listening skills
• Ability to communicate precisely and accurately to all levels of the organization
• Strong interpersonal and project management skills
• Aptitude for identifying creative solutions to complex customer issues
• Excellent time management and multitasking skills
• Strong written and verbal communication skills
• Ability to work well in a team environment
• Strong commitment to quality, customer service, and patient safety
• Self-motivated, self-directed, and able to work with minimal supervision
• Continuous and versatile learner