Associate Quality Management Complaint SpecialistKLS Martin • Jacksonville, FL, United States
Associate Quality Management Complaint Specialist
KLS Martin • Jacksonville, FL, United States
13 days ago
Job type
- Full-time
Job descriptionAssist 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 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 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 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 Sitting for extended periods Extended periods viewing computer screen Walking Reading Speaking Hear / Listen Maintain regular, punctual attendance Writing Normal office environment
Job Details
Job Location
Corporate Office - Jacksonville, FL
Remote Type
Fully Remote
Position Type
Full Time
Education Level
4 Year Degree
Travel Percentage
None
Job Shift
8 : 00am - 5 : 00pm
Description
- 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
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.
Qualifications
Education and Experience Requirements
Knowledge, Skills, and Abilities
Skill Requirements :
Physical Requirements :
Hazards :
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Quality Management Specialist • Jacksonville, FL, United States
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