About the Job

The Sr Dir, Quality Assurance is responsible for the design, development, implementation and maintenance of a compliant and effective software design & development, risk management, change management, and software lifecycle management system. This includes partnering with the Technology and IT organizations to ensure processes are compliance, dynamic and agile to meet the demands of the business. The incumbent is responsible for identifying and securing needed resources to ensure effectiveness.

Key Responsibilities

• Partner with FMI Senior Management to facilitate quality and compliance activities related to software development and lifecycle activities. Partner with cross functional team members to drive quality improvement activities and lean principles within the organization. 
• Ensure that software design and development practices incorporate current global regulatory compliance expectations as required by IEC 62304, ISO 13485, ISO 14971, and other applicable regulations/standards.
• Responsible for directing the efforts associated with QA functions related to software quality engineering, software change management and the software development lifecycle.
• Lead software quality engineering and technical support for product realization and market release and lifecycle management.
• Oversite and leadership of quality events related to software products.
• Responsible for the ownership, harmonization and ongoing management of software development SOPs and Work Instructions working with key stakeholders to ensure efficient and effective procedures/processes.
• Ensure software development projects are resourced and supported through the design and development process.
• Assist in establishing robust programs to ensure new software products/solutions are designed and compliant to all applicable regulations.
• Ensure software for FMI used in the medical device and laboratory space are appropriately validated for their intended use.
• Partner with appropriate Technology and IT partners to drive CAPAs to closure in a timely manner.
• Manage the process for software risk management activities throughout the software lifecycle.
• Function as the Subject Matter Expert on software design and development and risk management matters.
• Lead software design transfer/deployment activities to ensure success of new designs in manufacturing.
• Function as the quality champion for Technology/IT projects impacting the quality assurance function and/or systems.
• Design, establish, implement and maintain a resource plan that fully supports the needs of the business to support growth initiatives.
• Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s degree in science, engineering or related field and 12+ years of experience working in the medical device industry; OR,
• Master’s degree and 10+ years of experience working in the medical device industry
• 5+ years of experience managing Software Quality Assurance in the Medical Device Industry

Preferred Qualifications

• Master’s or Advance Degree in science, engineering or related field
• Experience with In Vitro Diagnostics
• Extensive knowledge of IEC 62304, ISO 13485, FDA CFR 820, IVDR, ISO 14971 and emerging standards and regulations
• Continuous improvement experience preferred (6 Sigma, Lean, GreenBelt/Black Belt)
• Excellent team building and leadership skills that motivate team members to drive projects to a successful conclusion; must be able to manage and lead without direct authority
• Excellent judgment skills in order to provide strong guidance and counsel to the site and line staff
• Time management skills for oneself and of others on a team, ability to drive projects to scheduled completion
• Strong data analysis skills
• Superior interpersonal, verbal and written communication skills 
• Exceptional organizational, negotiation, and problem-solving skills
• Demonstrated ability to work in a matrixed organizational structure, developing strong relationships with all levels of management
• Understanding of HIPAA and importance of patient data privacy
• Commitment to reflect FMI’s values: passion, patients, innovation and collaboration.

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