Job Details

Weekly Hours: 40

Role Number: 200650171-0836

Summary

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 Special Projects group is looking for a Production Quality Engineer to oversee Quality engineering activities, and support quality management system efforts for its medical device products. We’re looking for innovative thinkers and doers who are passionate to make a real impact in people’s lives.

Description

We are looking for a cross-functional Quality team member, working closely with Engineering, Project management, and Post-Market surveillance teams. This role is critical in driving product and process issue resolution, implementing Quality improvements, performing risk assessments, and ensuring clear communication and timely progress reporting across teams. This person will ensure that products meet Quality goals, and regulatory requirements including but not limited to FDA Quality System Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971, while defining and implementing standard operating procedures (SOPs).

This is a site-based role.

Minimum Qualifications

• B.S. ME/EE/BME/CS degree or equivalent in any Engineering/Science discipline

• 5+ years of Medical device experience in a Quality/Regulatory role

• Familiarity with 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations

• Experience interpreting requirements and following standard operating procedures

• Experience with design control and risk management activities for Medical devices, including development and maintenance of design history files

Preferred Qualifications

• Experience working on software and hardware products within a Quality or regulatory system.

• Expertise in execution of design controls.

• Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.

• Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.

• Strong organizational and leadership skills.

• Excellent communication skills, both verbal and written.

Apple is an equal opportunity employer that is committed to inclusion and diversity. We seek to promote equal opportunity for all applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, Veteran status, or other legally protected characteristics. Learn more about your EEO rights as an applicant (https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .