Quality System Lead (Head of QMS/ Management Representative), Health China

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 Principle Quality System Lead to support regulated features in China. 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.

Description

Develop and maintain a robust quality system to ensure regulatory compliance and continuous improvement.
Supports region specific manufacturing registrations
Guides team members on the implementation of the quality system requirements.

Minimum Qualifications

Bachelor’s Degree, or equivalent experience.
7-10 years of experience in Quality Management Systems supporting Medical Devices.
Extensive experience in managing, maintaining and implementing quality management systems
Excellent written and verbal communication skills
Strong customer service orientation and corresponding skills
Excellent interpersonal skills working across multiple divisions
Attention to detail, well organized and time efficient
Can multi-task and work independently
Knowledge of domestic medical device regulatory requirements (China GMP)
Technical writing skills
Proficient in English both oral and written
Experience leading and managing regulatory audits

Preferred Qualifications

Knowledge of international medical device regulatory requirements