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Complaint Management Associate

Company: Volt
Location: Boise
Posted on: March 26, 2020

Job Description:

Complaints Management Associate I GENERAL SUMMARY:The Complaints Management Associate supports Complaint Management Specialists during the product complaint submission process by drafting Medical Device Reports (MDRs). - This role works closely with and is in constant communication with the Complaint Management Specialists they support in order to ensure MDRs are submitted correctly and in a timely manner.PRIMARY DUTIES & RESPONSIBILITIES: Reviews assigned product complaint records and drafts MDRs that are submitted to the FDA as part of the overall complaint management process required for medical device products. Effectively supports complaint handling process to ensure timely completion of complaint and MDR activities. Supports Complaint Management Specialists in the drafting and filing of Medical Device Reports to ensure timely submission of adverse event reporting to FDA. Uses and maintains database(s) and/or logs to track complaint and MDR activities. Assists with the closure of complaints. Assists with processing of complaint records under the supervision of Complaint Management Specialist. Participates and supports departmental and quality system audits. Assists in the training of new Complaint Management Associates. Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements. Other responsibilities as assigned.REQUIRED QUALIFICATIONS: Knowledge, skills & abilities: Basic knowledge of ISO, FDA and cGMP concepts and guidelines preferred. Familiar with the QSR and ISO13485 requirements preferred. Basic knowledge of medical devices, their development and quality control. Able to effectively share information related to work product in verbal and written form. Demonstrated ability to work accurately, follow instructions and schedules, and handle multiple priorities. Strong computer skills, including Microsoft Word, Excel, PowerPoint, and Outlook. Excellent written communication skills with the ability to write business and technical documents with minimal supervision. Able to manage assignments with flexibility and adaptability in accordance with project priorities and by altering course of action when and where necessary. Strong attention to detail. Demonstrated experience working in a fast-paced, high volume environment.Minimum certifications/educational level: Bachelor's degree in relevant field preferred or equivalent combination of education and applicable job experience.Minimum experience: 2 years' administrative support experience Medical device or biomedical field experience preferred.JOB SCOPE: Acquires job skills and learns company policies and procedures to complete tasks. Works on assignments that are routine in nature, requiring limited judgment. Normally receives detailed instructions and works under close supervision.PHYSICAL REQUIREMENTS: While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment. - Employee may occasionally lift and/or move up to 45 pounds.Volt is an equal opportunity employer.PandoLogic. Keywords: Quality Complaint Handler, Location: Boise, ID - 83725

Keywords: Volt, Boise , Complaint Management Associate, Executive , Boise, Idaho

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