Temporary Doc Control Specialist
About The Position
Join us today and make a difference in people's lives! LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company is listed on the NASDAQ stock exchange under the ticker symbol " LIVN ." LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide. 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.
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 demonstated office and customer service skills.
- Skilled in the use of Microsoft Office, Electronic Documentation Management Systems (EDMS) and quality training programs.
- Excellent written and verbal communications skills
- Associates degree or equivalent work experience
Nice To Haves
- Previous experience in FDA regulated industry is a plus.
Responsibilities
- 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Administrative and Support Services
Education Level
Associate degree
Number of Employees
1,001-5,000 employees
