Quality Manager - Health Special Projects
Santa Clara Valley (Cupertino), California, United States
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. Do you want to help deliver the next amazing Apple product? Our teams feature a collaborative environment with creative, smart people and groundbreaking technologies. Come, join us in crafting solutions the world doesn’t know of yet.
- You've built a novel quality management system from the ground up
- Familiarity with 21 CFR 820, ISO-13485, and other applicable regulations
- Must have experience interpreting requirements and writing procedures
- Experience deploying and validating electronic systems for use in a regulated environment
The QE Manager will be responsible for leading and mentoring the quality team and will ensure execution of the quality management system. You will maintain communication within the feasibility team; maintain project schedules; cross-functional organization, communication, and management. You will ensure licenses and registrations are in place, including maintaining ISO 13485 Certification. You'll be expected to present to senior management on project status and schedules. The Quality Manager will interact with all engineering design disciplines, data analysis, and additional project management teams. We are looking for someone who is flexible and can respond quickly, energetically, and enthusiastically to changes. Cross-functional communication skills and experience are essential.
Education & Experience
B.S. ME/EE/BME/CS degree or equivalent in any engineering discipline
- 3-5 years of Quality/Compliance team management in a medical device or digital health organization
- Good organizational and management skills
- Excellent communication skills
- Proven ability to work cross functionally