Lilly Advisor-Quality Assurance in Cambridge, Massachusetts
The Lilly Innovation Center in Cambridge, Massachusetts allows Lilly to explore how next generation therapeutics, emerging technologies, data analytics and new models can improve patient health while reducing the clinical, psychosocial and economic burden that is systemic throughout healthcare today. Our team in Cambridge shares a passion for challenging conventional wisdom and crafting an environment that embraces prioritizing high-risk, breakthrough concepts.
Quality Assurance plays an integral role at this site. The Quality Assurance group defines design assurance quality strategy for new projects during product innovation and concept phases. We oversee the development of design control planning activities and deliverables to ensure compliance with applicable industry guidance and regulations. We work with FDA guidance for content of premarket submission for software contained in medical devices and FDA General Principles on software validation.
We are seeking an Advisor-Quality Assurance to lead the Quality efforts at Lilly’s Cambridge Innovation Center. You will contribute by providing technical quality assurance support to cross-functional product innovation and concept development team(s) by applying you knowledge of design control principles, quality engineering techniques and application of Agile Practices in the development of medical device software to the innovation efforts. You will work to ensure that concept designs are developed in accordance with applicable industry standards, regulatory requirements, and customer requirements as well as leading the effort for site implementation of quality system elements as necessary. Do you have a passion to work successfully in complex and emerging technologies, leveraging interpersonal and technical skills to optimize results? Is yes, this may be the position for you!
Responsibilities of the Advisor-Quality Assurance include:
Identify and develop quality agreement requirements to support the establishment of multi-party innovation design efforts
Participate in identifying and managing risk throughout the innovation and concept phases and ensuring that initial risk plans are appropriate and transferable to the Lilly development risk management process
Provide Quality oversight for innovation activities focusing on implementing a streamline design/development planning process for proof of concept, early phase feasibility and CT studies for mechanical and electromechnical medical devices, medical device software as well as MMA for combination products / medical device systems
Serve as the quality lead for facilitating the integration of Agile methodology into device QMS by addressing regulations and guidance’s (Such as AAMI TR 45:2012) for producing medical device software
Ensure innovation and concept system, hardware, and software design reviews, test plans and protocols are appropriately developed and executed
Oversee the development and qualification of instruments/test systems/tools used to create and test concept combination products/medical systems/software
Ensure development and implementation of appropriate site quality systems elements necessary to support the entire end-to-end product innovation and concept phases including design service partners, testing laboratories, and contract manufacturers an associated supply chains
MS in Electrical, Computer/Software, or Biomedical Engineering. Other fields with electrical engineering focus acceptable, if experience demonstrates proficiency in Infusion Pump hardware/software development
Self- starter, with the ability to work independently and with all levels of management, project leaders, project associates, and clients
Ability to effectively influence and negotiate with all levels of an organization and leading effective/successful change initiatives including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes
Demonstrated knowledge of Quality System Regulations (QSR), design control systems, ISO 13485, CE Marking, ISO 14971 and cGMP
Demonstrated knowledge of IEC60601 and IEC 62304 and other relevant medical device and medical device software development standards/guidance’s
Knowledge and demonstrated expertise in supplier development, systems engineering, requirements management, risk/issue management, safety assurance case development
Experience with test systems design and development
Possess strong analytical & problem solving skills
Excellent judgment and strong critical thinking skills
- Position functionally reports to the Global Device Quality Leader and will be a contributing member of the Cambridge MA site lead team which is under direction of the Cambridge MA site head. The position will be located at the Lilly Innovation Center (Cambridge, MA), with up to 25% travel to Lilly Technology Center- North in Indianapolis, Indiana and partner sites as required.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Advisor-Quality Assurance Connected Care
BS in Engineering or Science
10+ years of experience in regulated environment
Demonstrated quality assurance knowledge of combination product / medical device product development and commercialization requirements. Specific demonstrated quality assurance experienced associated with the development and commercialization of electromechanical medical devices, software applications and medical device software is preferred
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world
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