Medical Device Development Quality Assurance

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 35,000 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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The role is accountable for understanding and guiding Lilly’s medical device development needs (including combination products) per current Lilly and regulatory requirements. This role will participate in planning (both operational and strategic) to support our development needs. This participation requires the ability to influence project teams on the development of compliant products by leveraging and integrating Lilly and vendor processes and tools.

Responsibilities:

• Define compliance requirements for project teams and participate in identifying specific deliverables for clinical trials and commercial product.
• Ensure Quality Management System compliance by providing input and/or updates to procedures as appropriate.
• Participate in or lead Root Cause Investigations.
• Ensure development, risk management, human factors activities, tasks and deliverables are complete by conducting Design Control document reviews and Phase audits.

Knowledge Requirements:

• All aspects of product development under design controls.
• Practical understanding of ISO 13485:2016 and FDA’s Quality System Regulation.
• Practical understanding of risk management per ISO14971, and human factors per AAMI HE75 and IEC62366,
• Practical understanding of design verification and design validation.
• Experienced with performing regulatory compliance reviews and auditing. Experienced working with development teams under multiple product development projects.

Basic qualifications

• Bachelor’s degree in STEM field with 2+ years of experience in a regulated and/or commercialization environment

Additional Skills

• Experience managing multiple tasks concurrently.
• Excellent verbal and written communication skills.
• Excellent team collaboration skills.

Additional Information

• Includes up to 10% international travel.
• This position reports to the Associate Director of Lilly IDM Quality and will have accountability for quality governance and oversight for medical device and/or combination product development projects.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

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