Sr Director, Quality Assurance - Software

Details of the offer

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 compliant, 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, market release, and lifecycle management.Oversight 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 with 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 the 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 industry5+ years of experience managing Software Quality Assurance in the Medical Device IndustryPreferred Qualifications Master's or Advance Degree in science, engineering, or related fieldExperience with In Vitro DiagnosticsExtensive knowledge of IEC 62304, ISO 13485, FDA CFR 820, IVDR, ISO 14971, and emerging standards and regulationsContinuous 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 authorityExcellent judgment skills in order to provide strong guidance and counsel to the site and line staffTime management skills for oneself and of others on a team, ability to drive projects to scheduled completionStrong data analysis skillsSuperior interpersonal, verbal, and written communication skillsExceptional organizational, negotiation, and problem-solving skillsDemonstrated ability to work in a matrixed organizational structure, developing strong relationships with all levels of managementUnderstanding of HIPAA and the importance of patient data privacyCommitment to reflect FMI's values: passion, patients, innovation, and collaboration.
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Nominal Salary: To be agreed

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