Associate Quality Management Complaint Specialist I

*This role is remote, however applicants must be located within 50 miles of KLS Martin's Jacksonville location. In addition, applicants must be authorized to work in the U.S. without the need for current or future visa sponsorship*

Associate Quality Management Complaint Specialist

Job Summary

Works to develop, implement, and maintain quality management system processes and the complaint handling process. Exercises discretion and independent judgement related, but not limited to, adverse event and the quality management system.

Essential Functions, Duties, and Responsibilities

• Assist in day-to-day complaint processing including in-take, follow-up, reporting, and SAP processing
• Reviews and analyzes customer complaints
• Initiates and completes MDRs for timely submission to FDA and other regulatory bodies
• Assists with recalls and advisory notices
• Tracks and communicate adverse event data and performs trending analysis
• Maintains current knowledge of FDA and international regulations, guidance and standards applicable to company products and
• Communicates with outside parties in a professional and customer-focused manner
• Support internal audits and external audits
• Assist with controlled documentation relating to complaint processes
• Assist with corrective and preventive actions implementation
• Monitor NCMRs and analyzes data
• Performs other related duties as assigned

The above cited duties and responsibilities describe the general nature and level of work performed by people assigned to job. They are not intended to be an exhaustive list of all the duties and responsibilities that an incumbent may be expected or asked to perform.

Education and Experience Requirements

• 4-year degree plus 4 years work experience in a regulated industry, or
• 8 years of experience in regulated industry
• Proficient user of Microsoft Office applications, with intermediate knowledge of MS Excel
• SAP experience preferred

Knowledge, Skills, and Abilities

• Maintains high integrity and confidentiality of company and department information
• Ability to work effectively with all levels of internal and external associates, customers, and colleagues
• Excellent interpersonal skills with the ability to effectively communicate at all levels internally as well as externally
• Ability to follow through on issues, make informed decisions that comply with policies and procedures, complete tasks and problemsolve
• Ability to retrieve and interpret documentation
• Ability to work with minimal supervision
• Ability to manage multiple priorities

Skill Requirements:

• Typing/Computer keyboard
• Utilize computer software (specified above)
• Retrieve and compile information
• Verify data and information
• Organize and prioritize information/tasks
• Advanced mathematical concepts (fractions, decimals, ratios, percentages, graphs)
• Verbal communication
• Written communication

Physical Requirements:

• Sitting for extended periods
• Extended periods viewing computer screen
• Walking
• Reading
• Speaking
• Hear/Listen
• Maintain regular, punctual attendance
• Writing

Hazards:

• Normal office environment