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.
This position provides Supplier Quality / Purchasing Controls support to Indianapolis Device Manufacturing (IDM), Delivery and Device Research & Development (DDR&D), and Contract Manufacturing Operations (CMO). This role will:
Be responsible for development and maintenance of an effective and robust Purchasing Controls and Supplier Management / Quality System ensuring consistent application of medical device regulations across IDM and DDR&D.
Support GMP compliance, Pre-Approval and General Inspections by various regulatory agencies, notified bodies, and internal audits.
Perform internal assessments and external audits on an as needed basis to support IDM, DDR&D, and CMOs.
Provide leadership, guidance, and consultation on Quality Standard/Regulations, Quality Systems, and Quality Issues surrounding the Quality Management System including yet not limited to supplier management, investigations, deviations, change controls, procedures, and device master record development and revisions, validations, and batch dispositions.
Bachelor’s Degree in Science or Engineering
Minimum of five (5) years industry related experience in quality roles supporting medical device manufacturing or equivalent (automotive, aerospace, consumer goods).
Minimum of three (3) years industry related experience Supplier Quality Assurance / Purchasing Controls Management.
Experience with ISO9001 and / or ISO13485
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.
Problem Solving and Decision-Making skills, with emphasis on Data-Based Decisions, and Customer Service.
Strong Technical Writing skills and proficiency in Technical Review of documents.
Minimum of seven (7) years industry related experience in Quality Assurance.
Minimum of three (3) years industry related experience in performing internal and/or supplier audits.
Knowledge and experience with Regulatory Requirements (e.g., 21CFR Parts 4, 11, 210 and 211, 820, 803, and 806; ISO 14971; Canadian MDR; EU Medical Device Directive/Regulation; JPAL; and other country specific MOH regulations).
Experience in negotiating Quality/Service Agreements
Experience in Process Validations supporting Injection Molding and / or High Speed Assembly
Experience with mechanical and / or electro-mechanical medical device manufacturing
Lean process experience
Demonstrated Teamwork and Interpersonal skills with internal and external partners.
Strong Administrative and Organization skills.
Demonstrated ability to influence others without authority
Ability to influence diverse groups.
Ability to work independently with a high degree of ownership and accountability
Ability to multi-task and work under ambiguous situations
Experience with applications such as Trackwise, Regulus, SAP, and Microsoft Office applications
Availability during off-work hours and weekends to provide support as needed
Shift is days (some off-shift and weekend work may be required)
Position is located at LTC-North
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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