SUMMARY

Provides for the creation and development of medical device design and quality documentation as well as the management and control of our Quality Management System, including the documents, records and associated processes. Works with technical teams to establish criteria and best practices for document development, management, and change control. Establishes and maintains a central repository, including history files, for all controlled Quality & Regulatory documents and records. Perform various duties essential to the implementation and execution of our electronic documentation system, including coordinating efforts for the control of new and updated Quality System procedures for ISO/QMSR.

ESSENTIAL JOB RESPONSIBILITIES AND DUTIES INCLUDE

• Ensure the consistency and quality of AVI product, process, and policy documentation in strict compliance to corporate policies, regulations and standards, from document creation to hard-copy and electronic filing to document obsolescence
• Assist technical team in the use of documentation standards, such as protocols, reports, procedures, material and assembly specifications, customer documentation, and product labeling.
• Ensure the consistency and quality of documents with the change control process.
• Identify, generate and publish Quality metric reports related to Document Control and Training.
• Facilitates the effective processing of quality system documents to ensure they are maintained and archived in an organized and retrievable state (manual or electronic) for accountability and access for any regulatory body.
• Establishes and maintains library of product and process-related reference standards, regulations, guidances, clinical articles and journals.
• Support the AVI Quality Management System as required, including continuously streamlining and improving QMS procedures and supporting Internal and External Audits.

REQUIREMENTS

• A minimum of 3 years of experience in a medical device design/manufacturer environment responsible for documentation control. Minimum of an Associate's Degree in a Science or Technical discipline. Multiple certifications specific to medical device quality and/or standards may be considered for a non-degreed professional, along with equivalent industry experience.
• Familiarity with documents that support the following in a medical device environment: new product development (protocols, reports, software, validation data, Design History Files), quality system (procedures, forms, quality records), and manufacturing (Device Master Record, Bills of Material, routers, procedures, Device History Records) documentation
• Past experience with electronic documentation control systems
• Exposure of 21 CFR Part 11 and Computer/Quality System Software management methods preferred
• Strong verbal and written communication skills and effective interpersonal skills.
• Ability to multitask, prioritize and meet deadlines.
• Must to be to work independently or as part of a team
• Experience in data entry, handling electronic files
• Above average organizational skills, detail-oriented while being flexible, able to adapt to changing priorities is required.
• Proficiency with Microsoft Office, Access, Visio, Project
• Proficiency with technical document source applications such as Adobe Acrobat, Framemaker, SolidWorks, Illustrator is highly recommended.