Quality Assurance Specialist-Junior
Bridgewater, NJ (Hybrid)
6-12+ Months contract
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.
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
Skills:
Bachelor degree required; in a Science, Math or Engineering related field is preferred
1-3 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, problem-solving, analytical and time management skills is desired
Competencies:
Proficient with Microsoft Office (Excel, Word, and PowerPoint)
Ability to learn database software
Ability to follow documented procedures
Ability to interface with both technical and non-technical personnel at all organizational levels
Ability to read and understand technical documentation including investigations and Service Orders
Ability to understand device, drug and/or biologic operational activities is desired
Excellent interpersonal, written English, and oral communication skills
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.
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