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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.
In 1992, Eli Lilly and Company established the Delivery Device business for the purpose of creating, developing, launching and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery and Device Research and Development (DDR&D) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users’ needs and intended uses. This business enables almost $4.0 billion in pharmaceutical sales and is projected to double in the next 6 years.
As a response to this growing portfolio along with increasing global regulatory expectations, we are seeking a highly motivated professional, reporting to the Manager Quality Assurance. This Quality Representative position is responsible for Quality oversight of medical device development projects and primary packaging development projects from proof-of-concept through launch. This individual must be versed in device regulations, as well as have experience with implementing Design Controls.
Quality oversight of Delivery and Device R&D activities:
Quality support of the product development teams in medical device design control from Proof of Concept through Launch.
Influence and support teams, alliance partners, and Contract Manufacturers on Quality Systems,
Design Controls and Design History File requirements.
Quality support of clinical trial lot release process
Review/approve documents including protocols, technical reports, deviations, change controls, inspection procedures, specifications, drawings, sampling plans, and validation packages.
Participate in Risk Management Activities including Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and/or Safety Assurance Cases
Support continuous improvement projects
Assist with internal audits and supplier audits (including due diligence) and maintain supplier development partnerships.
Consult/work with Regulatory to assure compliance with applicable registrations, standards, guidances and requirements.
Support of Quality System initiatives (periodic reviews, self-assessments, CAPA, Development Quality Agreements, etc.) as needed.
Bachelor's Degree in scientific discipline
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.
Experience with electronics/software embedded in medical devices.
Technical knowledge in device, primary packaging, or drug development.
Working knowledge of drug or device quality systems.
Technical knowledge of regulatory requirements (e.g. 21 CFR Parts 210, 211, and 820, ISO 13485, Canadian MDR, Medical Device Directive).
Experience with insulin pumps or patch pumps.
Experience in risk management tools with emphasis on Safety Assurance Cases
Experience with Computer System Quality/Software Validation
Basic knowledge in statistics and its application.
Demonstrated interpersonal skills with internal and external partners
Location is at Lilly Technology Center – North, in Indianapolis
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. .
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