Senior QMS Development Engineer - Medical Devices

Apple • Cupertino, CA

1d • Onsite

About The Position

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 QMS Development Engineer 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 QMS Development
Engineer will be responsible for designing, implementing, and optimizing quality
system processes that ensure our quality management system meets global
regulatory requirements in an efficient manner. This is a site-based role.

Requirements

• Bachelor’s Degree, or equivalent experience.
• 7+ years of experience in Quality Management Systems supporting Medical Devices.
• Six Sigma Green/Black Belt.
• Excellent written and verbal communication skills
• Experience presenting to executive management
• Knowledge of medical device regulatory requirements (e.g. ISO13485, MDSAP requirements, China GMP, EU MDR etc…)
• Strong project management skills—ability to lead cross-functional teams without direct authority.
• Experience with AI/ML

Nice To Haves

• Experience with software as a medical device
• Experience with eQMS software
• Excellent interpersonal skills working across multiple divisions
• Attention to detail, well organized and time efficient
• Can multi-task and work independently

Responsibilities

• designing, implementing, and optimizing quality system processes that ensure our quality management system meets global regulatory requirements in an efficient manner

What This Job Offers

• Job Type: Full-time
• Career Level: Senior