Position location must be in San Diego, CA, Chicago, IL, Hartland, WI or Daytona, FLIBM Watson Health is looking for talented individuals destined to usher in the next era of healthcare. We live in a moment of remarkable change and opportunity. The convergence of data and technology is transforming healthcare and life sciences organizations today. New opportunities are being created that never existed before to meet the demands of this transformation. We have an exciting opportunity for a Director Of Quality Affairs supporting Merge healthcare products and services. Specific areas of interest include: healthcare external audit requests, FDA and ISO regulatory healthcare environments and healthcare Quality Management Systems.IBM Merge, is a leading provider of innovative enterprise imaging, interoperability and clinical solutions that seek to advance healthcare. IBM Merge’s enterprise and cloud-based technologies for image intensive specialties provide access to any image, anywhere, any time. IBM Merge also provides intelligent solutions and software for clinical trials.Candidates will be expected to have Healthcare Quality Management Systems experience in one or more of the areas of interest mentioned above. Additionally, they are expected to have strong verbal and written communication skills and experience with managing and leading direct reports, and presenting to senior executive leaders. We are looking for self-motivated and driven candidates that are passionate about working on cutting edge technologies and that thrive in a highly collaborative environment. Some of the essential job duties include the following:
Lead a team of quality professionals: mentor & coach direct and indirect reports.
Ensures that the Quality Management System is established, implemented, and maintained in accordance with the requirements established by FDA and other regulatory agencies. Includes ensuring conformance to industry and international standards as applicable and appropriate.
Educates and trains employees as to their impact in the Quality Management System
Review and implement strategies to improve existing processes and champion implementation of new initiatives across the solution development, implementation, and support functions to ensure consistency, compliance and best practice.
Assuring audit readiness and product compliance with regulations.
Hosts FDA and other regulatory inspections.
Hosts non-regulatory inspections: ISO or Customer request
Participates as an active and guiding member of product development program teams, providing guidance on Quality Management System processes and procedures.
Oversee the establishment of quality metrics and data analysis with appropriate corrective or preventive measures to ensure the continued suitability and effectiveness of the quality system.
Participate in Management Reviews
Minimum of 10 years in the medical device or healthcare industry including quality system audit experience.
Experience with implementations of quality system in accordance with FDA QSRs, ISO 13485, MDD, and CMDR.
Demonstrated knowledge of medical device quality system and clinical trial regulations with experience in a quality and/or regulatory department within the medical industry.
Ability to travel as needed to domestic and international (Canada) sites.
Experience managing a team of direct reports.