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.