Medical Device Quality Consultant
Eli Lilly and Company - Indianapolis, IN

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For more than 130 years, Lilly has been dedicated to meeting the health care needs of people in the United States and around the world. We address these needs primarily by developing innovative medicines—investing a higher percentage of our sales in research and development than any other major pharmaceutical company. If you are interested in being considered for employment with a “Best in Class” Pharmaceutical company, please review the following opportunity:

Medical Device Quality Consultant

The medical device quality consultant is primarily responsible for quality assurance oversight of medical devices and the device portion of combination products. This individual must have a working knowledge of worldwide medical device regulations, ensuring compliance with applicable global governing standards. The quality consultant will also be responsible for internal and external auditing against those applicable governing standards and regulations.

  • Utilize in-depth knowledge of medical device governing standards and regulations (e.g., 21 CFR Parts 210/211, 820 QSR, ISO 13485, ISO 14971,Canadian MDR, EU Medical Device Directive, JPAL) to ensure organizational compliance.
  • Possess fundamental knowledge of the Quality Management System for medical devices and the device portion of combination products to ensure alignment with applicable governing standards and regulations.
  • Perform internal and external audits (e.g., suppliers, contract manufacturers) as a lead or support auditor.
  • Facilitate and sustain a supplier management program by continually monitoring status of audit observations, action items, and supplier improvement initiatives.
  • Support site management in preparation of external audits performed on the device Quality Management System and assist with written response to outside audit agencies.
  • Serve as a liaison with regulatory affairs ensuring compliance with regulatory reporting requirements for medical devices and the device portion of combination products.
  • Provide guidance on CE marking strategies in support of emerging device portfolio.
  • Bachelors degree.
  • Knowledge of governing standards and regulations (e.g., 21 CFR Parts 210/211, 820 QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical Device Directive, JPAL).
  • Minimum of five (5) years industry related experience in areas which may include Quality, Technical Services, LRL Product Development, and/or Manufacturing of medical devices.
  • Technical knowledge in Quality System elements, devices, design, manufacturing and validation.
  • Auditing experience.
  • Experience interacting with outside regulatory agencies.
  • 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.
  • Demonstrated interpersonal skill for work with suppliers and contract manufacturers.
  • Ability to influence diverse groups.
  • Demonstrated oral and written communication.
  • Meets commitments and deadlines.
  • Demonstrated self-management/time-management skills.
  • Strong attention to detail.
  • Demonstrated decision-making and problem-solving skills.
  • Ability to work as part of a team.
  • Negotiating, mentoring skills.
  • Experience with Lotus Notes, Microsoft applications, Regulus, and TrackWise.
  • Travel: 25% related to auditing activities.
Lilly credits its exceptional employees for its successes, and knows the key to ongoing achievement lies in attracting and retaining the best people. A company rich in heritage, Lilly employs individuals, conducts research and markets products worldwide. By providing for the unmet needs of our customers through a continuous stream of innovation, we will outgrow all competitors.

Lilly earns consistent and wide recognition for creating an exceptional work environment while maintaining our highly regarded reputation in the Pharmaceutical Industry and Community:

  • FORTUNE Most Globally Admired Companies™
  • FORTUNE Top Companies for Leaders in North America™
  • Chronicle of Philanthropy Most Generous Companies in the US
  • Business Week Magazine Best Places To Launch A Career™
  • Information Week 500 Most Innovative Users of Technology
  • Science Magazine Best Companies for Scientists™
  • The Scientist Best Places to Work in the Industry™
  • Black Enterprise Top 40 Companies for Diversity
  • Working Mother Best Companies for Working Mothers™

About this company
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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...