Sensogram Technologies LLC
Quality Manager
Job Address
Application Deadline
Yerevan, Armenia
- Implement quality activities required to obtain and maintain ISO 13485 QMS certification. This includes correspondence for changes to the business or products including audits by ISO registrar. Quality Manager will work with the Global VP Quality and Regulatory regarding FDA regulatory correspondence for changes to the business or products as well as regulatory audits by the FDA as well as FDA registration and listing deliverables - Manages and Maintains QMS documentation through - Completes all Quality Records in manufacturing including, overseeing fixture calibrations and preventative maintenance, reviewing production travelers and maintaining the device history records - Executes tasks that are overseen by the Global VP Quality and Regulatory, including evaluating regulatory changes, participating in Management Review meetings, etc. - Execute tasks for the Quality Management System department including documentation control, quality training, internal and supplier audits, and all aspects of customer support complaint communication process including CAPAs, complaints and recalls. These responsibilities are executed under the oversight of the Global VP Quality and Regulatory - Executes duties as part of Design Control project management system. This includes supporting the construction of all Design History Files needed for FDA submissions. Collaborates with other departments (i.e. Development and Marketing) to execute tasks as needed - Responsibilities may include project definition, program management, product integration and system implementation by working with design engineers, product developers, clinical professionals, and customers. - Support customer service for complaint handling and notify Regulatory of any adverse events - Support the implementation of short- and long-range departmental goals, objectives, policies, and operating procedures as part of Management - Support and guide individuals and departments in the establishment, use, and continued improvement of the Quality Management System
Required Qualifications
- Minimum of 4-year degree in an engineering related field - Should have related experience in medical device and quality environment - Competency in project management and problem solving skills - Should have experience with medical device registration projects - Competency in interpersonal skills with diverse workforce. Written and verbal skills must be excellent Training: - Training may be defined by Global VP Quality and Regulatory based on job assignments - Additional training may be required based on job responsibilities and Competence, Awareness and Training procedure - HIPAA training is required
Application Procedures
Interested candidates are welcome to send their CV to: mentioning the position title in the subject line of the email. Please mention in your application that you have learned about this position from
Additional Information
The Quality Manager reports to the Global VP Quality and Regulatory and is responsible for enforcing and implementing the Sensogram Inc quality management system. The Quality Manager carries out duties for Quality Control, Quality Assurance, and Regulatory departments. Location: This position is based in Yerevan, Armenia with occasional travel to suppliers for quality audits and corporate offices in Plano, Texas USA.