Quality Management System Manager

                
Job Title: Quality Management System Manager 
Duration: 12+ months contract with possible extension
Location: Gainesville FL

Requirements:
Support Post QMS activities for EU MDR compliance 
Manages the transition/deployment of the PQMS and manage its deployment. 
Administers a compliant and effective QMS for the activities in scope 
Locally manages plan for all QMS parts in scope while maintaining a compliant and effective (local) QMS throughout the duration of the transition to the PQMS o Administers and contributes to the management of any local QMS documents 
Supports training and training administration as per the QMS and contributes to training content for local QMS documents as necessary. 
Work closely with cross-functional teams including Research and Development, Manufacturing, Quality Assurance, Marketing, and Complaint Management teams and international geographies to develop a QMS deployment strategy for multiple BIUs 
Work closely with other regulatory and clinical professionals to ensure all post market product data and clinical use information is adequately and correctly represented 
Analyzes complaint data, gathers additional data as needed, and partners cross functionally to provide feedback to the BIU supporting complaint evaluation and/or to the market 
Identify issues that need resolution to ensure continued registrations in all global markets planned for commercialization 
Participate in cross-functional meetings to provide detailed feedback of QMS, post market, and other quality implementation activities Knowledge of how to, or a willingness to learn to write protocols, reports, and other documentation to support international registrations 
We are looking for 
An individual with a quality/engineering discipline as related to medical device products 
5+ years of experience in manufacturing or product development environment 
5+ years of experience developing and writing product documentation 
Ability to understand how knowledge of device behaviors in clinical settings contributes to ongoing regulatory compliance and prevents market disruptions 
Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape 
Ability to work nimbly, using critical thinking, with an innovative approach to problem solving 
Ability to work with international cultures to obtain device performance data 
Knowledge of basic statistical methodology 
Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment 
Interest in and passion for the medical device industry, bringing innovation to market 
Effective working in multidisciplinary teams 
Good communication skills, written and verbal


Please send me your confirmation that no one else has contacted you for this position apart from APN Team.

Thanks and Regards,
Ali Khan
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560  
Direct: 510.870.8798 | Fax: 510.623.5055 | ali@apninc.com


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