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Quality Assurance Specialist-Junior

HonorVet Technologies
  • Bridgewater, NJ
  • $35–$44 Per Hour
  • Quick Apply
4 days ago

Job Description

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

LocationBridgewater, NJ
IndustryStaffing/Employment Agencies
Salary$35–$44 Per Hour
Company Size50 to 99 employees
Year Founded2015
Websitehttp://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
  • Customer Support/Serviceunmatched
  • Customer/Client Researchunmatched
  • Database Management Software/Systems (DBMS)unmatched
  • Disability Accommodationsunmatched
  • English Languageunmatched
  • Federal Governmentunmatched
  • Fortune 500 Customersunmatched
  • ISO (International Organization for Standardization)unmatched
  • ISO 9001unmatched
  • Interpersonal Skillsunmatched
  • Investigative Reportsunmatched
  • Marketingunmatched
  • Mathematicsunmatched
  • Medical Affairsunmatched
  • Medical Equipmentunmatched
  • Medical Recordsunmatched
  • Metricsunmatched
  • Microsoft Excelunmatched
  • Microsoft Officeunmatched
  • Microsoft PowerPointunmatched
  • Microsoft Wordunmatched
  • Operations Processesunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Product Managementunmatched
  • Product Reviewsunmatched
  • Product Testingunmatched
  • Quality Assuranceunmatched
  • Quality Engineeringunmatched
  • Quality Managementunmatched
  • Regulationsunmatched
  • Research & Development (R&D)unmatched
  • Safety/Work Safetyunmatched
  • State Governmentunmatched
  • Technical Recruitingunmatched
  • Technical Writingunmatched
  • Time Managementunmatched
  • Trend Analysisunmatched
  • Writing Skillsunmatched

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