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Quality Engineer, Sustaining - Health



Quality Assurance
Cupertino, CA, USA
Posted on Friday, June 7, 2024


Weekly Hours: 40
Role Number:200553712
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 Quality Engineer to perform sustaining quality engineering activities, and support Quality management system efforts for its software medical device products.


The Quality Engineer needs to be able to prioritize issues and track the details, as well as be in touch with the big picture issues. We are looking for someone who is flexible and can respond quickly and enthusiastically to changes. This person will interact with all engineering disciplines and project management teams. You will be responsible for handling communications, preserving project schedules, crafting meetings with detailed action items and progress, and reporting and presenting to multi-functional teams. You are also responsible for: - Leading risk management activities in relation to design changes, and issues discovered during internal testing, and in the field - Identifying and implementing effective systems to support products post market - Owning the execution of systems which identify and resolve quality issues (CAPAs) - Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues - Leading and implementing various product and process improvement methodologies in regards to quality issues - Working with the teams on investigation, resolution and prevention of product and process non-conformances - Supporting initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements - Aligning with applicable regulatory requirements, procedures, and processes, requirements

Minimum Qualifications

  • BS/ME/EE/BME/CS degree or equivalent in any engineering/ science field
  • 3+ 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 with design control, and risk management activities for medical devices, including development and maintenance of design history files

Key Qualifications

Preferred Qualifications

  • Experience interpreting requirements and following standard operating procedures
  • Outstanding organizational and management skills
  • Excellent interpersonal skills, both verbal and written
  • Experience in working on software products within a quality or regulatory system

Education & Experience

Additional Requirements

Pay & Benefits

  • Apple is an equal opportunity employer that is committed to inclusion and diversity. We take affirmative action to ensure 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.