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 others 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. Its 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 youll do more than join something youll add 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. nnThe Senior Lead Auditor will lead and maintain a risk based internal u0026 supplier audit program to ensure ongoing regulatory compliance and encourage continuous

Subject matter expert on the quality management system audit processesnIndependently supports internal audit program. nGenerates and schedules audits per a risk based audit schedulenConducts 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)nManages and supports the supplier quality programincluding but not limited to: qualification of suppliers supplier corrective actions and supplier monitoring. nGenerates audit reports outlining audit objectives and results nSupports external audits via audit preparation and execution nIndependently monitors changes to key global regulations and ensures policies and procedures reflect applicable changes and implements quality system best practicesnMaintain appropriate audit credentials

Bachelors Degree or equivalent experience. n5 years of experience in Quality Management Systems supporting Medical experience in performing audits to regulatory requirements nKnowledge of medical device regulatory requirements (e.g. ISO 13485 MDSAP requirements China GMP EU MDR China GMP etc) nExcellent written and verbal communication skillsnExcellent interpersonal skills working across multiple divisionsnAbility to be onsite; this role is a hybrid in-person positionnSome travel is required

Experience with software medical device products nLead auditor certification or internal auditor certificationnAttention to detail well organized and time efficientnCan multi-task and work independently