Job Title: Quality Management System Manager
Duration: 12+ months contract with possible extension
Location: Gainesville FL
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,
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560
Direct: 510.870.8798 | Fax: 510.623.5055 | firstname.lastname@example.org