What are the responsibilities and job description for the Sr Director, Quality Assurance - Software position at Foundation Medicine?
Job Description
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
Preferred Qualifications
LI-Hybrid
About Us
Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE / AAP Employer)
