Principal Quality Auditor - Devices

Employer
Lilly
Location
Indianapolis
Salary
Competitive
Posted
February 07 2017
Discipline
Life Sciences
Position Type
Full Time
Organization Type
Pharma
Job Type
Other
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
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 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
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