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.

MINIMUM REQUIREMENTS:

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.

Experience interacting with outside regulatory agencies is a minimum requirement.

Travel: 25% related to auditing activities.

If you are interested in finding out more about this position, please send resume to:

recruiter04@contractstaffingrecruiters.com