OVERALL RESPONSIBILITIES:
Customer Quality member responsible for supporting Post Market Regulatory Affairs activities associated with complaint handling and MDR submissions. These activities include intake, investigation, documentation, follow-up, regulatory reporting and metrics. The Customer Quality Specialist is responsible for the oversight and direct support of technical evaluations and investigational tasks required for complaint processing/closure. The Customer Quality Specialist works collaboratively with Quality, Engineering, Manufacturing, Product Development and other functional experts.
DUTIES:
• Responsible and accountable for on-time submission and accuracy of regulatory reports
• Review and complete determination associated Medical Device Report and/or Vigilance Report
• Knowledge of and familiarity with global regulations for reporting
• Directly interface with service centers, Hospitals, Surgeons, and Internal employees for reporting of complaints and adverse events
• Interact positively with internal, external business partners and colleagues
• Adhere and comply to work instructions, standard operating procedures, and regulations
• Expedite investigations by collaborating with internal/external business partners
• Achieve productivity targets
• Fully trained within three months of hire
• Achieve accuracy targets for complaint documentations
• Participate in projects and events
• Complaint determination
• Reportability assessments
• Conduct follow-ups with complainant, reporters
• Checking your own work
• Updating SharePoint
• Tracking complaints in the process for closure
• All other duties as assigned
• Bachelor’s Degree or equivalent experience
• Generally requires 2-4 years of related work experience
• RAC or ASQ certifications a plus
All your information will be kept confidential according to EEO guidelines.
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Established in 2000, A Minority Business Enterprise (MBE), LanceSoft Inc. is a pioneer in providing premium end-to-end Professional IT/Non-IT Contingent Workforce Solutions and IT Services to diverse clients across various domains. Core Service Offerings We offer a gamut of services across diverse domains, categories, skill sets with varying lengths of assignments, that include, but are not just limited to: - Temporary Staffing - Permanent Staffing - Payrolling - Recruitment Process Outsourcing (RPO) - Back-office Services - Application Design and Development - Website Design and Development - Program/Project Management Our Domain Strength With currently over 1000+ staff serving over 49 clients worldwide including “Fortune” companies, LanceSoft serves a wide array of industries including Healthcare/Pharma, Clinical/Medical Devices, Technology, Telecom, Retail and Distribution, Energy & Utilities, Banking, Finance, Insurance, Manufacturing, Automobile, Media, Transportation, and Government Sectors. Geographic Coverage LanceSoft is headquartered in Herndon, Virginia and has a network of branch offices across the US in Chicago (IL), Irving (TX), Basking Ridge (NJ), Atlanta (GA) and San Diego (CA). We also have an International footprint with two country offices in Canada (ON and BC) along with three delivery centers in India- Bangalore, Indore and Hyderabad to further help serve our clients better. We currently operate and recruit in 49 US states catering to diverse Contingent Workforce needs of our clients. Awards and Accolades Following are some of our awards and accolades in the US Contingent Workforce space: - Manpower “Premier Vendor” – 2014 - Kelly’s “Supplier Innovation Award” – 2012 - Kelly’s “Supplier of the Year” Award – 2012 and 2011 - Kelly’s “Service Excellence Award” – 2010 and 2009 - “Stewardship Recognition” from Johnson & Johnson’s (J&J) Kelly Work sense program Specialties IT/Non-IT Contingent Workforce Services, Creative Solutions, Temporary/Permanent Staffing, Recruitment Process Outsourcing, Payrolling, Application Design and Development, Back-office Services, Program/Project Management, Website Design and Development