Global Document Control Analyst

Purpose

Responsible for providing Document Control support across multiple sites for the administration of the quality system in accordance with international standards and regulations (such as ISO 13485, MDSAP MDD-MDR, QSR, etc.).

Key Responsibilities

• Maintain and manage the electronic document management system (set up new users, adjust training plans, manage daily queries)
• Support the organisation in raising, reviewing and releasing change orders to ensure accuracy and effective change management of the QMS
• Provide, collate and present data in Quality Review forums and audits
• Manage the training program and ensure employees are trained to current revisions of their assigned procedures
• Provide training within the organisation on the document and change management process
• Identify and execute improvements to the document lifecycle and associated processes
• Review completeness of documentation for all Quality Records, including approvals, implementation of corrections and redlines, and overall content
• Maintain logs, trackers and Quality Records
• Create and organize indexes and master lists of documents, and provide administrative support across the organization
  
  

Qualification

• Knowledge of ISO 13485:2016/MDSAP/MDD-MDR
• Knowledge of Document Control
• Computer literate with a good working knowledge of Microsoft Office (Word, PowerPoint, Excel)
• Familiar with creating PDFs
• Ability to effectively present information and respond to questions from stakeholders
• Fluent in English (spoken and written)
• Ability to follow direction with high attention to detail
• Ability to multitask and be comfortable with changes in priorities
• Collaborative, and willing to learn
• Excellent communication and organizational skills
  
  

Company

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com