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Quality Assurance-Electromechanical Device Manufacturing - United States  

Lilly (company)

Posted on : 13 May 2017

Project Description

Quality Assurance-Electromechanical Device Manufacturing
United States
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 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.

  • Bachelor’s Degree in Science, Engineering or other related fields
  • 5 years in a quality or technical role within the Pharmaceutical or Device Industry (Regulated Environment)
  • Electromechanical experience, preferably with Bluetooth
  • 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 development or manufacturing of medical device pumps
  • External auditing experience
  • Knowledge of medical device regulations and QMS elements
  • Project leadership experience
  • Previous Supervisory Experience (3 years minimum)
  • Contract manufacturing experience preferred but not required
  • Effective communication, interpersonal and networking skills
  • Ability to explain validation to those not trained in validation concepts
  • Ability to build collaborative relationships with both internal and external customers
  • Demonstrated ability to influence others without authority
  • Ability to work independently with a high degree of ownership and accountability
  • Ability to multi-task and work under ambiguous situations
  • Demonstrated knowledge of Lilly's Quality Management System and GMPs
  • Full time position
  • Position is located in Indianapolis
  • Availability during off-work hours or weekends to provide project team support may be 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.