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Senior Lead Auditor (Medical Devices)

Apple
Posted 8 days ago, valid for 16 days
Location

Cupertino, CA, US

Salary

Competitive

Contract type

Full Time

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Sonic Summary

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  • Apple is seeking a Senior Lead Auditor for its Health group, focusing on regulated medical device features.
  • The role requires a minimum of 5 years of experience in Quality Management Systems related to Medical Devices and a Bachelor’s Degree or equivalent experience.
  • The Senior Lead Auditor will oversee a risk-based internal and supplier audit program to ensure regulatory compliance and promote continuous improvement.
  • Candidates should have extensive auditing experience with knowledge of medical device regulatory requirements such as ISO 13485 and EU MDR.
  • This hybrid position offers competitive compensation, although specific salary details are not provided in the job description.
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.

Description


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.

Minimum Qualifications


Bachelor’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 Some travel is required Ability to be onsite; this role is a hybrid, in-person position

Preferred Qualifications


Experience 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



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