Device Tracking And Data Entry Specialist

Essential Duties And Responsibilities

The Device Tracking and Data Entry Specialist is responsible for retrieval and entry of Device Tracking/Warranty Enrollment forms into the DevTrak database. This position makes corrections to entries upon receipt of corrections and updates and assists in the creation and provision of Device Tracking reports. This position is also responsible for the maintenance and update of the documentation records and files in both the internal controlled document files and in the SmartDoc™ module of the SmartSolve® QMS.

The initial base salary for this position is up to $24.00/hour. You will also be eligible for generous benefits and a 401(k) with contributions from Sientra.

Additional Duties And Responsibilities

• Other duties as assigned.
• Assist in the maintenance of the DevTrak database and associated systems, including associated spreadsheets and databases and facilitate the ongoing improvement of the Device Tracking process.
• Supports and participates in other QA projects and activities as needed.
• Provide guidance and assistance to other Device Tracking data-entry personnel.
• Assist in the maintenance and update of the SmartSolve® QMS, including entry of new and revised actor, contact, part and process data as required and as it become available.
• Facilitate the scheduled audits of the Device Tracking process, including reporting findings and assisting in the creation of audit reports relative to the Tracking system.
• Provide assistance for Management Reviews and Internal Audits.
• Assist in the maintenance and update of the GUDID database for the UDI process.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Requirements (Education, Certificates, Licenses, Registrations, Etc.)

• One-two years of experience in an office/professional environment, preferably in healthcare, biotechnology or other related field(s).
• Minimum preferred: BS in biology or healthcare related discipline; alternatively, a BS in business administration with a focus on business systems and experience with business analytics; or equivalent combination of education and experience

Language Skills

Ability to read, analyze and interpret technical procedures or governmental regulations. Ability to write reports and contribute to business correspondence.

Computer Skills

Ability to use word processing, spreadsheet and database applications at an advanced level. Ability to facilitate and participate in validation of software programs. A high level of understanding of data processing and programming.

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of the job, the employee is regularly required to sit, talk and hear, lift and/or move up to 10 pounds, stand, walk, climb or balance in conditions that include stairs, uneven ground, walking between buildings, etc. Normal vision is required for this job (with corrective lenses if necessary). The work environment is somewhat quiet.

This description contains the essential functions necessary to evaluate the position. It is not intended and should not be used as an exhaustive list of all responsibilities, skills or efforts.

FLSA Status: Non-Exempt

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