Job Summary

The person hired for the position of Manager Software Quality Assurance will be responsible for leading the Software Quality Assurance team and implementing and maintaining the Engineering tools and processes.

Primary Responsibilities include but are not limited to the following:

• Leads the Software Quality Assurance team
  
• Works closely with Software team to define testing methodology
  
• Facilitates the planning and execution of Software quality management plans
  
• Develops strategies to improve software quality operations
  
• Conducts resource management, forecasting, and work assignments
  

Develops the team

• Tracks metrics on appropriate scorecard
  
• Implements appropriate test automation processes and tools
  
• Leads the development & maintenance of engineering tools as it relates to system and Software based on FDA regulations.
  
• Develop implementation of engineering tools
  
• Develop work instructions and roll-out training to cross functional teams
  
• Manages tool releases and qualification according to 21 CFR part 11
  
• Schedule, plan and lead project & process audits in Engineering organization
  
• Works closely with Quality team to implement processes within the QMS framework
  
• Participate in field surveillance program.
  
• Collaborates with a network of resources (contracts & proposals, technical leads, project delivery management, software engineering/development, research and development, support) to facilitate completion of assignments including process optimization and continuous improvement
  
• Manages customer expectations with regard to Software quality
  

Basic Qualifications:

• Bachelors degree or higher from an accredited university
  
• Minimum of five (5) years combined experience in Quality Management and/or Process Improvement
  
• Minimum of five (5) years combined experience leading and executing software quality assurance
  

Preferred Qualifications:

• Bachelors degree or higher in Electrical Engineering, Software Engineering, Information Technology or related discipline from an accredited institution
  
• Minimum of five (5) years of experience working in a highly networked organization
  
• Experience with Lean Six Sigma methods and Minitab
  
• Experience with SW development tools such as Jira, Jama, Integrity, Confluence
  
• Experience with Quality Manuals, International Organization for Standardization (ISO)-9001, ISO-27001, ISO-12207, ISO-15288 and audits
  
• Ability to influence at all levels