Senior Lead Auditor - Medical Devices

Apple is where individual imaginations gather together, committing to the values that lead to great work. Every new product we build, service we create, or Apple Store experience we deliver is the result of us making each other's ideas stronger. That happens because every one of us shares a belief that we can make something wonderful and share it with the world, changing lives for the better. It's the diversity of our people and their thinking that inspires the innovation that runs through everything we do. When we bring everybody in, we can do the best work of our lives. Here, you'll do more than join something - you'll add something.

Our ever-evolving suite of Heath and Wellness products for iPhone and Watch are helping our users live more active, healthier lives. Be ready to make something great when you come here. Dynamic, inspiring people and innovative, industry-defining technologies are the norm at Apple. The people who work here have reinvented and defined entire industries with our products and services. The same dedication to innovation also applies to our business practices -strengthening our commitment to leave the world better than we found it. 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.

Subject matter expert on the quality management system audit processes Independently supports internal audit program. Generates and schedules audits per a risk based audit schedule Conducts audits in accordance to ISO 13485, MDSAP requirements, China GMP, EU MDR and other international regulatory requirements; as well as conformance to applicable product and process standards (e.g ISO 14971, ISO 62366, ISO 62304, etc) Manages and supports the supplier quality program,including but not limited to: qualification of suppliers, supplier corrective actions, and supplier monitoring. Generates audit reports outlining audit objectives and results Supports external audits via audit preparation and execution Independently monitors changes to key global regulations and ensures policies and procedures reflect applicable changes and implements quality system best practices Maintain appropriate audit credentialsBachelor'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 Ability to be onsite; this role is a hybrid, in-person position Some travel is requiredExperience 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