Temporary Doc Control Specialist

Job Purpose

This position is responsible for supporting the Document Control team in processing document change orders and maintaining product design history files to support the quality system and product design records. This individual works collaboratively with all areas of the business to ensure documents are controlled per regulatory requirements and processed aligned with procedures. Additional job requirements in support of the new product development, related to documentation and change control may be assigned to support new product development.

Major Accountabilities

• Prioritize setup of design files and coversheets, organizing attachments, submission and release of vendor-provided documents into the EDMS to support the new product development.

• Create and maintain a Design History File (DHF) index in Sharepoint to track vendor-provided design files with associated document numbers, revisions, assignments, and release.

• Support the documentation process for Quality Engineering (QE) by formatting, submitting, and processing change plans and documents.

• Processes document change controls and change orders to ensure revision control in alignment with regulatory requirements and existing procedures.

• Assists with special projects as assigned based on approved quality plans and/or improvement initiatives.

• Assist with DHF maintenance by auditing released versions in EDMS versus latest vendor revision.

• Cross-train to support Quality Training Coordinator to assist with data entry of training records and filing of training records.

• Cross-train in Quality Engineering (QE) to maintain change management records (Polarion software system) and records in support of new product development.

Key performance indicators/ Measures of success

• Processes controlled documentation in a timely manner with few mistakes.

• Masters new process to process and track vendor-provided documentation in LivaNova documentation system.

• Follow-up with submission and approvers to ensure timely evaluation and release of documents

Education

• Associates degree or equivalent work experience

Minimum Requirements

• Minimum of 1 year of experience in document control / document management and/or maintenance of quality records.

• Minimum of 1 year experience in office environment with demonstarted office and customer service skills.

• Previous experience in FDA regulated industry is a plus.

• Skilled in the use of Microsoft Office, Electronic Documentation Management Systems (EDMS) and quality training programs.

• Excellent written and verbal communications skills

Pay Transparency

• A reasonable estimate of the hourly pay rate for this position is $26/hour - $28/hour. Pay ranges may vary by location and will be based on relevance and depth of experience.