Senior Lead Auditor - Medical Devices
About The Position
The Health group is looking for a Senior Lead Auditor to support regulated medical device features. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands. The Senior Lead Auditor will lead and maintain a risk based internal & supplier audit program to ensure ongoing regulatory compliance and encourage continuous improvement. This is a site-based role.
Requirements
- Bachelor’s Degree or equivalent experience.
- 5+ years of experience in Quality Management Systems supporting Medical Devices.
- Extensive experience in performing audits to regulatory requirements
- Knowledge of medical device regulatory requirements (e.g. ISO 13485, MDSAP requirements, China GMP, EU MDR, China GMP, etc…)
- Excellent written and verbal communication skills
- Excellent interpersonal skills working across multiple divisions
Nice To Haves
- Experience with software medical device products
- Lead auditor certification or internal auditor certification
- Attention to detail, well organized and time efficient
- Can multi-task and work independently
Responsibilities
- Lead and maintain a risk based internal & supplier audit program to ensure ongoing regulatory compliance and encourage continuous improvement.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
