Overview
On Site
$20 - $24 /hr
Contract - Independent
Contract - Long Term
Skills
"complaint handling" AND (cGMP OR Clinical OR "Medical device" OR "FDA" OR "MDR") AND investigation AND risk AND (writing OR written OR write) AND ("continuous improvement" OR CAPA OR "Product Improve
Job Details
Stefanini Group is hiring!
Stefanini is looking for Complaints Specialist in Medina, NY (Hybrid)
For quick Apply, please reach out to Tuhin Podder- call: /email:
Work Hours: M-F (40 hours)
Work Location: Medina, NY (Hybrid)
Shift: 1st Shift
Position is responsible for complaint handling, will triage incoming complaints for the assigned team, and will process all levels of complaints without supervision. Triage incoming complaints from internal or external customers to determine next steps in the process based on level of risk. Collect necessary complaint information for investigations. Determine reportability of a complaint. Respond to customer complaints (written or verbal) and write technical investigation response letters. Participate in continuous improvement activities and projects (ie: CAPA, Product Improvement Teams). May lead projects assigned by management. May have technical approver responsibilities. Manage workflow; identify and escalate issues. Participate in mentoring and training of the Product Surveillance team. Ability to perform all duties required of previous levels. The incumbent will perform other duties assigned.
Bachelors degree required. 2-5 years relevant work experience in cGMP related industry or in a clinical setting. Will need strong writing experience. Strong knowledge of the FDA Quality System and Medical Device Reporting regulations (21 CFR 803, 806, 820, and 211). Understanding of the products intended use and manufacturing process of assigned products. Strong technical writing skills, able to review complaint investigations and write customer response letters. Readily accepting of assignments to new/ different products. Ability to prioritize multiple risk projects to ensure compliance with regulations and standard operating procedures. Excellent written/verbal communication and organizational skills. Ability to make independent decisions with minimum oversight. Strong problem solving and analytical skills. Knowledge and application of computer systems for word processing, reporting, data analysis and complaint management. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore, onshore, and near shore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities. Stefanini is a CMM level 5, IT consulting company with a global presence. We are CMM Level 5 company.
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