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Quality Assurance-Electromechanical Device Manufacturing United States,
Posted on : 13 May 2017
Req ID 33344 Title Quality Assurance-Electromechanical Device Manufacturing City Indianapolis State / Province Indiana Country United States Workplace Arrangement Local Company Overview 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. Responsibilities This position will serve as a Quality Assurance representative for oversight of medical devices and the device portion of combination products in support of product commercialization. This requires a working knowledge of medical device regulations and contract manufacturing standards to facilitate the technical transfer of medical devices in the emerging Indianapolis Device Manufacturing (IDM) portfolio. The Quality Assurance rep will be responsible for ensuring design for manufacturability and manufacturing readiness for prospective contract manufacturers (CM) and suppliers.Additionally, the Quality Assurance rep will also provide guidance on GMP compliance during preparations for Pre-approval and General Inspections by various regulatory agencies. 33344BR Basic Qualifications Bachelor s Degree in Science, Engineering or other related fields5 years in a quality or technical role within the Pharmaceutical or Device Industry (Regulated Environment)Electromechanical experience, preferably with BluetoothQualified 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. Additional Skills/Preferences Experience with development or manufacturing of medical device pumpsExternal auditing experienceKnowledge of medical device regulations and QMS elementsProject leadership experiencePrevious Supervisory Experience (3 years minimum)Contract manufacturing experience preferred but not requiredEffective communication, interpersonal and networking skillsAbility to explain validation to those not trained in validation conceptsAbility to build collaborative relationships with both internal and external customersDemonstrated ability to influence others without authorityAbility to work independently with a high degree of ownership and accountabilityAbility to multi-task and work under ambiguous situationsDemonstrated knowledge of Lilly's Quality Management System and GMPs Additional Information Full time position Position is located in IndianapolisAvailability during off-work hours or weekends to provide project team support may be requiredLilly 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.
Indiana, United States
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