Quality Assurance Specialist-Junior

Stellar IT Solutions LLC; Bridgewater (MA); On-site; USD 60,000 - 85,000; Full time

Job summary

Stellar IT Solutions LLC is seeking a Quality Complaints Specialist to manage daily product quality complaints, coordinate investigations, and ensure timely closure in the system. You will interact with customers via phone and email, review trends, and support regulatory audits and inspections.

The role emphasizes adherence to global quality guidelines (21 CFR, ISO 13485, MDSAP, EU MDR) and collaboration with R&D, Engineering, and Operations to resolve issues efficiently.

Job description

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.