QMS Engineering Manager - 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.\\n\\nOur 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. \\n\\nThe Health group is looking for a Manager of the QMS Engineering team 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 QMS Engineering Manager will be responsible for overseeing a team of engineers responsible for the validation of all non-product software used in the design and production of medical devices. Beyond maintaining a compliant state, this leader is responsible for optimization by implementing automation and AI. This team manages the tools and systems that build the product.\n\nThis person will oversee a team of validation engineers responsible for the optimization of the quality management system (including non product software) and managing the lifecycle of the software systems. This includes the following activities:\n Non product software validations \n QMS Process Optimization \n Integration of AI in the quality management system

Bachelor's Degree or equivalent experience \n10+ years of experience in Quality Management Systems supporting Medical Devices\nSix Sigma Green/Black Belt \nKnowledge of medical device regulatory requirements (e.g. ISO13485, MDSAP requirements, China GMP, EU MDR etc...) \nStrong project management skills-ability to lead cross-functional teams without direct authority\nAbility to influence stakeholders to adopt modern techniques\nExperience with AI/ML\nExperience with eQMS software\n

Excellent written and verbal communication skills\nExperience presenting to executive management \nExcellent interpersonal skills working across multiple divisions\nAttention to detail, well organized and time efficient\nCan multi-task and work independently\nExperience with software as a medical device \nPMP Certification