Quality Project Manager Medical Devices (Extension Professional II)
Job Title: Quality Project Manager Medical Devices (Extension Professional II)
Location: Atlanta, Georgia
Full/Part Time: Full-Time
Job ID: 220487
Serving within the Research Faculty of The Institute, this position directly supports the extension, service, and economic development missions of Georgia Tech to the State of Georgia and beyond. Primarily this position serves within the Georgia Tech MEP (Manufacturing Extension Partnership) of the Enterprise Innovation Institute (EI2). Extension Professionals are responsible for initiating, conducting, reporting and follow-up of technical projects for the focused (but not exclusive) client customer base defined as the small to mid-size manufacturer (<500 employees). EI2 Extension Professionals are expected to manage projects independently and report measurable outcomes through internal metric reporting systems required by federal sponsors.
Specifically, GaMEP has created this position in response to a significant increase in demand to support medical device manufacturing companies, and those aiming to enter the market, since early 2020. This specific position will report to the GaMEP’s Group Manager of the Operational Excellence team and will be expected to have a strong background in Quality Management, and specifically, quality management and regulatory requirements related to medical devices. Service delivery will focus on providing assistance to Manufacturing clients within, or those newly entering, the medical device industry in all areas of quality management and regulatory compliance. General quality management and quality engineering deliverables outside of the medical device industry will be expected as well, based on the successful candidate’s skillset – for example, delivering training/projects in International Organization for Standardization (ISO) 9001-2015, Lean Six Sigma, Root Cause Analysis, etc.Responsibilities
• Develop project opportunities from initiation through delivery. In general, this includes, but is not limited to: evaluating client needs, facilitating groups for identifying/solving problems, collaborating with appropriate constituents to meet project objectives/requirements, assigning and/or performing project follow-up activities, and presenting project findings/recommendations.
• Assist medical device industry clients with the development and implementation of regulatory approvals and compliant quality management plans.
• Work with clients to identify gaps in existing quality management/engineering programs and consult with them to develop effective corrective actions to ensure compliance.
• Train industry clients on a wide variety of medical device regulatory and management system topics.
• Serve as the Georgia Manufacturing Extension Partnership’s expert in Medical Device quality management systems, ISO 13485, U.S. Food and Drug Administration (FDA) compliance, National Institute for Occupational Safety and Health (NIOSH) registration, etc.
• Perform organizational administrative tasks, and other related duties, as assigned.
- Education: MS degree in Engineering, Technology, Business, or related field.Work Experience: Minimum 5-7 years of experience implementing quality assurance programs in a mid-to-large scale medical device facility (or equivalent combination of education and work experience).Skills: This job requires working knowledge of general manufacturing processes (preferably in the medical device industry) as well as ability to perform sales, marketing, and customer service from a consulting delivery perspective. This job also requires public speaking/presentation, process analysis and problem-solving, as well as use of standard office equipment and specialized computer applications. Successful candidates will be able to demonstrate a reputable track record in project management with an ability to interpret/present data in logical and client-understandable fashion. Travel: Incumbents in this position are expected to travel, as needed, and remain flexible to on-site daily service delivery hours (due to client shift schedules and/or project requirements).
The Georgia Manufacturing Extension Partnership (GaMEP) helps manufacturers increase top-line growth and reduce bottom-line costs. With nine regional offices across the state, GaMEP offers a solution-based approach through coaching, implementation, and training in areas such as:
Strategic Planning – developing and incorporating organization-wide strategies into overall business plan and day-to-day operational tactics.
Innovation Management – creating and sustaining a process to grow businesses and feed an ideation pipeline.
Process Improvement – applying continuous improvement solutions in lean (5S, value stream mapping, kanban, kaizen events, and more) to manufacturing plant and front-end processes.
ISO Standards – implementing and modifying quality- (ISO 9001), environmental- (ISO 14001), and energy-management (ISO 50001) systems.
Sustainability – incorporating sustainable environmental and safety solutions.Energy – integrating best practices in energy efficiency and management. Technology Acceleration – Locating and transferring technology to improve internal processes and/or market existing technology out to improve competitiveness into new adjacent markets. To learn more about GaMEP visit: http://gamep.org/ Georgia Tech Extension Professionals are research personnel assigned to fulfill the extension service mission of Georgia Tech to the State of Georgia and beyond. This mission includes, but is not limited to, technology-based economic development, technology commercialization and deployment, entrepreneurship, start-up company incubation, and business/industry outreach. Extension Professionals also provide educational programs for business and industry in support of these missions through facilitating and fostering increased industrial engagement and sponsorship of applied research activities at Georgia Tech. Extension Professional appointments are based on the merit and special qualifications of the individual and follow the same general ranking, hiring, and promotion principles as other professional research faculty ranks.