What are the responsibilities and job description for the Evaluation Specialist position at Dexian?
Job Title: Complaint Evaluation Specialist - Medical device
Location: Acton MA
Duration: 6-Month Initial Contract (Potential 6 – 12-month extension)
Pay rate - $30- 33/hour
The Complaint Evaluation Specialist position is accountable for individual projects as well as training and documentation in support of other team members. The Specialist may also review and monitor data and document quality, as requested by the manager. This position will provide administrative support to the department through assistance in the preparation of data analysis, reporting, trending, and documentation review, coordination of complaints and lot qualification data, device history reviews and review and closure of certain categories of complaints. It also requires assessment of complaints against regulatory reporting criteria. The position involves system level comprehension, attention to detail, organization, and constant interaction within the business to the accomplishment of the company goals.
Responsibilities:
• Track all stages of the Complaint Documentation process including:
• Reportability Determination, • Data Analysis, • Reporting and Trending, • Documentation Review, • Coordination of complaint and lot qualification data, • Device history reviews, • Review and closure of certain categories of complaints. • Maintain accurate documentation and files related to special projects, complaints and lot Qualification. • Review and analyze lot documentation (DHRs) to determine if there are any anomalies that may have related to reported product failures. • Support database development and reporting capabilities related to the complaint / reliability department needs. • Assist during FDA, ISO or other third party or internal audits. • Train others on the requirements of the Complaint Coordinating activities, including follow-up with the Customer Care Group. • Support review and investigation of adverse events • Perform basic product review and failure analysis. • Performs other duties as required.
Education and Experience:
Minimum Requirements:
• Bachelors degree or 3 years of demonstrated experience in medical device complaint evaluation or vigilance reporting
• Complaint handling experience preferred • Minimum of 1-2 years experience in data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude and data management.
Preferred Skills and Competencies: • Willingness to pursue additional learning and build qualifications in a professional field, as required. • Ability to demonstrate system level expertise of databases with the ability to train on these identified systems. • Effective verbal and technical writing skills. Ability to communicate at multiple levels of an organization. • Ability to organize and judge priorities. • Excels at generating and maintaining organized and accurate records, PC skill, word processing, spreadsheet, database. • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/
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to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.
Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development, and Dexian IT Solutions. Visit https://dexian.com/ to learn more.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status
Disclaimer:- The information contained in this electronic message and any attachments to this message are intended for the exclusive use of the addressee(s) and may contain proprietary, confidential or privileged information. If you are not the intended recipient, you should not disseminate, distribute or copy this e-mail. Please notify the sender immediately and destroy all copies of this message and any attachments. The views expressed in this E-mail message (including the enclosure/(s) or attachment/(s) if any) are those of the individual sender, except where the sender expressly, and with authority, states them to be the views of Dexian DISYS. Before opening any mail and attachments please check them for viruses. Dexian DISYS does not accept any liability for virus infected
Saniya Inamdar
Technical Recruiter
Phone: 201-595-0351
www.dexian.com
Email: saniya.inamdar@dexian.com
LinkedIn: linkedin.com/in/saniya-inamdar-40839720b
Got feedback? Please email BusinessExcellence@dexian.com
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Disclaimer:- The information contained in this electronic message and any attachments to this message are intended for the exclusive use of the addressee(s) and may contain proprietary, confidential or privileged information. If you are not the intended recipient, you should not disseminate, distribute or copy this e-mail. Please notify the sender immediately and destroy all copies of this message and any attachments. The views expressed in this E-mail message (including the enclosure/(s) or attachment/(s) if any) are those of the individual sender, except where the sender expressly, and with authority, states them to be the views of Dexian DISYS. Before opening any mail and attachments please check them for viruses. Dexian DISYS does not accept any liability for virus infected mails
Disclaimer:- The information contained in this electronic message and any attachments to this message are intended for the exclusive use of the addressee(s) and may contain proprietary, confidential or privileged information. If you are not the intended recipient, you should not disseminate, distribute or copy this e-mail. Please notify the sender immediately and destroy all copies of this message and any attachments. The views expressed in this E-mail message (including the enclosure/(s) or attachment/(s) if any) are those of the individual sender, except where the sender expressly, and with authority, states them to be the views of Dexian DISYS. Before opening any mail and attachments please check them for viruses. Dexian DISYS does not accept any liability for virus infected mails.
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Salary : $30 - $33