Quality Assurance Complaints Handling Specialist

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 pertaining to 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.

• Create and manage cases for more complex scenarios.
• Handle inbound and outbound calls efficiently and effectively.
• Resolve customer concerns by pinpointing problems and ensuring customer satisfaction.
• Maintain detailed records of outbound calls.
• Train personnel involved in the complaint process.
• Participate in training classes and maintain competency through ongoing training.
• Interact with cross-functional teams and raise escalated concerns to management.

Minimum Requirements/Knowledge

• Knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations.
• Product knowledge: understanding of product usage and the ability to differentiate between significant and non-significant health risks.
• Ability to handle complex customer inquiries and receive, review, and process purchase orders.
• Proven ability to maintain a professional demeanor when handling complex user issues and high-pressure situations.
• Excellent customer service skills: high level of interpersonal skills, strong attention to detail, and ability to handle multiple tasks simultaneously.
• Strong analytical, deductive reasoning, and listening skills.
• Strong interpersonal skills.
• Strong project management skills.
• Demonstrated aptitude for identifying creative solutions to complex customer issues.
• Excellent time management and multitasking skills.
• Excellent written and verbal communication skills.
• Continuous and versatile learner.

Education

• High School Diploma or Associate Degree.
• Bachelor’s or Master’s degree preferred and/or combination of education and relative experience in lieu of a degree.

Certifications

• Licensed Medical Professional 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 complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations.