Product Quality Complaints - GMP/21CFR ($38/hr W2)
Product Quality Complaints - GMP/21CFR ($38/hr W2)
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Summary: The primary responsibility of this position involves the daily management of commercial Product Quality Complaints. The daily management of complaints may include but not limited to complaint file creation identifying trends processing metrics ensuring timely investigations and closing complaints through the system in a timely manner.
This position works in an office type environment. Long periods of sitting are required. Use of computer and phone are required on a daily basis.
Skills:
Bachelor degree required; in a Science Math or Engineering related field is preferred
02 years of experience in a medical device biologics and/or pharmaceutical organization is desired
Experience in a regulated cGMP environment is desirable
Knowledge of regulations and standards (21CFR 820 21CFR 803 21CFR 210/211 MDD ISO 13485 CMDCAS MDSAP EU MDR etc.); as they apply to complaint management is desired
Demonstrated organizational problemsolving analytical and time management skills is desired
Job Responsibilities:
Capture review and analyze product complaints
Communicate with customers directly via phone and email
Identify customer feedback related to services products and processes
Comply with relevant global product quality related guidelines standards and regulations regarding the receipt review investigation and reporting of product experiences
Identify and understand the differences between product quality complaints adverse events / incidents medical information request customer feedback and regulatory agency requests
Collaborate with Field Personnel Quality Engineering and/or Operations personnel to process complaints in a timely fashion
Initiate coordinate review and summarize investigations for complaints
Perform product return evaluations as required
Identify potential product performance issues and alert the appropriate Management personnel as required
Escalate quality and/or safety concerns reported / experienced by the customer
Work in conjunction and effectively communicate with various departments including R&D Engineering Marketing Medical Affairs Technical Service and Customer Care
Provide support during audits and regulatory inspections as required
Perform other duties as assigned
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
