About Company
HonorVet Technologies is a Service-Disabled Veteran Owned IT staffing firm, ISO 9001 and ISO 27001 certified, working with federal agencies, state governments, and Fortune 500 enterprise clients across the US. What makes us different isn’t a tagline, it’s the way we work. We don’t forward resumes and hope for the best. We take the time to understand where a professional like you is headed and only reach out when we genuinely believe there’s a fit worth exploring.
Quality Assurance Specialist-Junior Location: Bridgewater, NJ 08827 Duration: 6+ Month Contract with possibility of extension and FTE Shift: Monday to Friday (9 to 5) Hybrid Onsite 3 Days Per Week (Tues, Wed. Thursday)
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
0-2 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
Note: Primary Duties for This Position
Capture, review, and analyze product complaints.
Technical and Soft Skills Required
Demonstrated organizational, problem-solving, analytical, and time management skills.
Preferred Experience
0–2 years of experience in a medical device, biologics, and/or pharmaceutical organization is desired.
Education Requirement
Bachelor's degree required; in a Science, Math, or Engineering-related field is preferred.
Numbers & Facts
Location
Bridgewater, NJ
Industry
Staffing/Employment Agencies
Salary
$35–$44 Per Hour
Company Size
50 to 99 employees
Year Founded
2015
Website
http://www.honorvettech.com
Benefits
401K, Employee Referral Program, Life Insurance
About Company
Is a leading Service Disabled Veteran Owned Small Business providing IT, Telecom and Medical Staffing.
Skills
Adverse Eventsunmatched
Analysis Skillsunmatched
Biotech and Pharmaceuticalunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Current Good Manufacturing Practice (cGMP)unmatched