Senior Quality Assurance Complaint Analyst - Miami, FL | Biospace
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Senior Quality Assurance Complaint Analyst

Beckman Coulter, Inc.

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Location:
Miami, FL
Posted Date:
9/14/2017
Position Type:
Full time
Job Code:
BEC007156
Salary:
Commensurate w/ exp
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Manage, coordinate, and perform tasks associated with triaging and in taking complaints. Reviewing complaints for trends and issues that pose a risk to the business.

MAIN JOB DUTIES/RESPONSIBILITIES

Administer and maintain the product complaint system:
Monitor and assist as required in the daily process of reviewing customer experience information, opening new complaint files, and updating electronic complaint database.
Evaluate the initial complaint information and identify any gaps against the required data.
Ensure that all fields within the CF record have been updated (e.g. contact date, event date, short/long description and all Type 1 question fields).If not, then update the record and or request the missing information from the customer or customer contact.
Note: The analyst is responsible for the initial request and not all three attempts.
Verify CF correctness of CF/Complaint Type and update if necessary. Document justifications for Type 2-5.
Open additional / separate CFs when multiple issues/ multiple patient events occur.
Interfacing with field personnel, Customer Service, Customers, and Engineering to obtain complete device and clinical information regarding reported events.
Escalate report ability issues involving death or serious injury to ensure adverse event reports for FDA and other international regulatory agencies are processed in accordance with the regulatory agencies.
Closely monitor complaints in draft status and ensure submission within a timely manner (as defined in GLB-QS-PCD-0004).
Monitor product performance and communicate with CHU Managers, engineering and design teams regarding product improvements or non- conformances.
Participate in Kaizens, workshops and Gemba activities to drive process improvement activities.
Create, implement, and update as needed work instructions pertaining to the analyst role as needed.
Contact customer with findings of CF/complaint investigation as needed, and document outcome of the customer call or write a customer letter.
Ensure compliance with applicable regulatory agency requirements, published standards, company policies/procedures, local procedures/work instructions, and project specific plans.
Upon request, performs specific data queries, prepares complaint reports, and communicates the results.
Other duties and projects as may be assigned.

Requirements

Bachelor’s degree plus five years or equivalent, preferably in a health field.
Master's degree with minimum three years of experience in the medical device industry or healthcare field.
Doctoral degree in field with 0-2 years experience
Working knowledge of GMP, ISO 13485, and MDD requirements.
Strong verbal communication skills and effective writing skills.
Strong computer skills in word processing and Microsoft Excel.
Ability to excel in a team oriented environment.
Additional preferred qualifications:
Experience in Risk Management concepts.
Direct experience with FDA complaint and adverse event management a plus.

Beckman Coulter is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.