Complaint Evaluation Specialist
Apex Systems, New York, NY, United States
Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients' digital visions.
Apex has an opportunity for a Complaint Evaluation Specialist.
For applicants who are interested in thisopportunity, send your updated resume to [email protected] .
Here are the details:
Position: Complaint Evaluation Specialist
Location: remote
Project Duration:3 months
Rate: Negotiable Based on Experience
JOB DESCRIPTION
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 (DHR's) 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:
• Bachelor's 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.
Physical Requirements (if applicable): • This position is a desk job and requires sitting for extended periods of time
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details.
Apex Benefits Overview:
Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Apex has an opportunity for a Complaint Evaluation Specialist.
For applicants who are interested in thisopportunity, send your updated resume to [email protected] .
Here are the details:
Position: Complaint Evaluation Specialist
Location: remote
Project Duration:3 months
Rate: Negotiable Based on Experience
JOB DESCRIPTION
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 (DHR's) 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:
• Bachelor's 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.
Physical Requirements (if applicable): • This position is a desk job and requires sitting for extended periods of time
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details.
Apex Benefits Overview:
Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.