IT Quality Manager - New York, United States - Tandym Group

Description

A medical organization is seeking an IT Quality Manager to join their team. In this role, the IT Quality Manager will be responsible for overseeing the development and maintenance of a robust quality management system within the Enterprise Information Technology department.

This is a Remote opportunity, however the qualified professional needs to be able to go in office as needed (couple times a month). Offices based in NYC, Westchester County, NY, Rhode Island, Kansas City, Delaware, and Minnesota.

Responsibilities:

The IT Quality Manager will:

• Coordinate with Quality and other business partners concerning supplier, external, and/or internal audits
• Conduct Failure Mode and Effect Analysis (FMEA) for new changes
• Develop, implement, and maintain a comprehensive quality management system for Information Technology processes and services
• Conduct regular audits to assess compliance with established quality standards and regulatory requirements
• Identify opportunities for process improvement within the Information Technology department to enhance efficiency and effectiveness
• Establish key performance indicators (KPIs) to measure and report on the quality of Information Technology services and processes
• Generate regular reports for management, highlighting areas of improvement and success
• Evaluate and ensure the quality of products and services provided by external vendors
• Identify and assess risks related to Information Technology quality and develop risk mitigation strategies
• Develop and deliver training programs to enhance the awareness and understanding of quality management principles among Information Technology staff
• Ensure validation/ testing deliverables comply with change management procedures, especially in areas that follow good manufacturing practices
• Acts as a liaison between end users and the Information Technology team to get an in-depth knowledge and understanding of the change in order to create requirements specification document
• Perform other duties, as needed

Qualifications:

• 5+ years of progressive software quality assurance and validation experience,
• At least 5+ years of hands-on experience in a regulatory environment (such as FDA, AABB, FACT, and/or NY State)
• Bachelor's Degree required in Quality Assurance, Operational Excellence, Information technology, or related discipline
• Knowledge of industry standard quality assurance and continuous improvement methodologies to ensure Information Technology systems deliver the intended performance and ensure they meet regulatory requirements
• Knowledge of cGMP, GXP regulations, including 21CFR part 11, and good documentation practices
• Familiar with Azure Devops, creating deployment tests, error coding, logging errors, etc.
• Experience in developing, consolidating, and implementing validation & testing strategy
• Ability to plan and efficiently organize job tasks or resources
• Ability to be responsive and available to management to address issues and concerns as they arise
• Ability to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
• Ability to identify complex problems on time, decipher information to develop and evaluate options and implement solutions

Desired Skills:

• Master's Degree
• Certified Process Validation Professional from CfPIE, ASQ
• Certifications or training in Quality Assurance, Operational Excellence, Total Quality Management, Continuous Improvement, and/or Lean/Six-Sigma