Senior Auditor-Quality Assessment Device Manufacturing - Indianapolis, IN | Biospace
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Senior Auditor-Quality Assessment Device Manufacturing

Eli Lilly and Company

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Location:
Indianapolis, IN
Posted Date:
4/28/2017
Position Type:
Full time
Job Code:
31444BR
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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.The primary responsibility for this position is to perform audits and provide audit support related to medical devices and combination products. This will include audits of contract manufacturers (CMO) of medical devices/device constituent of combination products, Lilly ISO certified sites, suppliers, and due diligence audits. This individual must have a strong knowledge of global medical device/combination product regulations and demonstrated experience auditing global quality systemsResponsibilities also include providing support to other QA staff with respect to reviewing audit responses, tracking corrective actions, trending, closure and supporting site regulatory inspections as needed Other duties and responsibilities as assigned by the Supervisor such as QS gap analysis, maintenance of Technical Files related to Quality Management System Bachelor’s Degree in Engineering or ScienceMust have a thorough knowledge of audit processes and previous experience leading and facilitating audits5+ years’ experience in a QA function in medical device or pharmaceutical industry3+ years’ experience auditing medical device or pharmaceutical industryQualified 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 positionTravel required up to 50% and includes both US and OUSLilly 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

Requirements

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.

*Basic Qualifications  
•Bachelor’s Degree in Engineering or Science
•Must have a thorough knowledge of audit processes and previous experience leading and facilitating audits
•5+ years’ experience in a QA function in medical device or pharmaceutical industry
•3+ years’ experience auditing medical device or pharmaceutical industry
•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

Additional Information  
•Travel required up to 50% and includes both US and OUS
•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

*Travel Percentage  
25-50%
*Responsibilities  
•The primary responsibility for this position is to perform audits and provide audit support related to medical devices and combination products.  This will include audits of contract manufacturers (CMO) of medical devices/device constituent of combination products, Lilly ISO certified sites, suppliers, and due diligence audits.
•This individual must have a strong knowledge of global medical device/combination product regulations and demonstrated experience auditing global quality systems
•Responsibilities also include providing support to other QA staff with respect to reviewing audit responses, tracking corrective actions, trending, closure and supporting site regulatory inspections as needed
• Other duties and responsibilities as assigned by the Supervisor such as QS gap analysis, maintenance of Technical Files related to Quality Management System

Additional Skills/Preferences  
•Knowledge of global medical devices and combination product regulations (e.g. 21 CFR 820, 21 CFR Part 210/211, 21 CFR Part 4, Canadian MDR, EU Medical Device Directives/CE Marking, JPAL, ISO 13485, ISO 14971, ISO 11608)
•Must possess excellent oral/written communication skills
•CQA Certification or ISO Lead Auditor certification preferred
•Demonstrated leadership skills and management experience
•Ability to show tenacity, persistence, face and deal with controversial issues
•Ability to work as part of a team
•Self-motivated and ability to work without supervision
•Experience with plastic molding operations and high speed automated assembly line equipment associated with medical devices/combination products