Auftragsdetails

Detailed Description

Job Responsibility:

• Maintains and supports quality activities required to obtain and maintain clients QMS 21 CFR Part 820.  Quality Manager will work with the Quality & Regulatory Consultants regarding FDA regulatory submissions including design control documentation and records.
• Executes tasks that are overseen by the Quality & Regulatory Consultants, including evaluating manufacturing and quality changes for the WRAP System (DEVICE).
• Executes duties as part of supplier management. This includes supporting the identification, qualification and oversight of suppliers and service providers needed for FDA GMPs. Collaborates with other departments (i.e. Development and Manufacturing) to execute supplier quality tasks as needed.
• Executes tasks for the Quality Management System department including documentation control, quality training, supplier audits, and all aspects of future customer support complaint communication process including CAPAs, complaints. Medical device reporting and recalls. These responsibilities are executed under the oversight of the Quality & Regulatory Consultants.
• Executes duties as part of manufacturing processing. This includes supporting the construction of all manufacturing work instructions, generating records, and providing training needed for FDA GMPs. Collaborates with other departments (i.e. Quality and Regulatory) to execute manufacturing quality tasks as needed.
• Executes duties as part of medical device 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.
• Contributes to project definition, program management, product integration and system implementation by working with design engineers, product developers, clinical professionals, and customers.
• Supports the implementation of short- and long-range departmental goals, objectives, policies, and operating procedures as part of Management.
• Supports and guides individuals and departments in the establishment, use, and continued improvement of the Quality Management System.

Job Qualifications:

• Minimum of 4-year degree in an engineering or quality related field.
• Preferred location Cleveland OH
• Relevant prior experience in a QM role.
• Competency in project management and problem-solving skills.
• Experience with medical device and GMP environment with emphasis on production and process controls.
• Competency in interpersonal skills with diverse workforce. Written and verbal skills must be excellent.
• Knowledge of software development lifecycle as part of design control a plus